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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA190193 | U.S. NIH Grant/Contract | View source |
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The research team is exploring device optimization
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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It has been well established that malignant tumors tend to have low levels of oxygen and that tumors with very low levels of oxygen are more resistant to radiotherapy and other treatments, such as chemotherapy and immunotherapy. Previous attempts to improve response to therapy by increasing the oxygen level of tissues have had disappointing results and collectively have not led to changing clinical practice. Without a method to measure oxygen levels in tumors or the ability to monitor over time whether tumors are responding to methods to increase oxygen during therapy, clinician's reluctance to use oxygen therapy in usual practice is not surprising.
The hypothesis underlying this research is that repeated measurements of tissue oxygen levels can be used to optimize cancer therapy, including combined therapy, and to minimize normal tissue side effects or complications. Because studies have found that tumors vary both in their initial levels of oxygen and exhibit changing patterns during growth and treatment, we propose to monitor oxygen levels in tumors and their responsiveness to hyperoxygenation procedures. Such knowledge about oxygen levels in tumor tissues and their responsiveness to hyper-oxygenation could potentially be used to select subjects for particular types of treatment, or otherwise to adjust routine care for patients known to have hypoxic but unresponsive tumors in order to improve their outcomes.
The overall objectives of this study are to establish the clinical feasibility and efficacy of using in vivo electron paramagnetic resonance (EPR) oximetry-a technique related to magnetic resonance imaging (MRI)-to obtain direct and repeated measurements of clinically useful information about tumor tissue oxygenation in specific groups of subjects with the same types of tumors, and to establish the clinical feasibility and efficacy of using inhalation of enriched oxygen to gain additional clinically useful information about responsiveness of tumors to hyper-oxygenation. Two devices are used: a paramagnetic charcoal suspension (Carlo Erba India ink) and in vivo EPR oximetry to assess oxygen levels. The ink is injected and becomes permanent in the tissue at the site of injection unless removed; thereafter, the in vivo oximetry measurements are noninvasive and can be repeated indefinitely.
The study design uses consecutively enrolled patients. Patients can participate as long as they are willing, fit the criteria for being assigned to a cohort, and the India ink spot remains measurable by EPR. Patients whose ink spot is resected during usual care and who do not have or are not willing to obtain additional injections will be withdrawn. Otherwise, patients can be re-measured using the previously injected ink at any time during the course of the study.
The study is split into four cohorts, with a minimum of 1-5 patients expected to be enrolled annually in each cohort, and a total of approximately 10 subjects expected for each cohort. The cohorts are defined by the type of tumor and by scenarios when our measurements will be made relative to the patient's standard therapies: 1) intraoral tumors with planned resection and adjuvant radiation therapy; 2) cutaneous malignant tumors receiving surgical resection only, receiving radiation therapy only, or receiving both surgical resection and adjuvant radiation therapy; 3) breast tumor receiving radiation therapy following surgery; and 4) other tumors receiving radiation therapy. The diagnosis for patients in all cases assumes that an eligible tumor (or the postsurgical area receiving radiation) occurs within approximately one-half centimeter of the surface, as determined by physical exam or imaging if available. All potentially eligible subjects are approached by their treating physician; those who agree to be contacted and are subsequently consented are assigned to the cohort for which they qualify. There is no randomization and no stratification within the cohorts.
Our interest in in situ tumor oxygenation relates to the clinical need to measure oxygen in tumors prior to therapy, to understand tumor oxygen dynamics over the course of therapy, and to assess the effectiveness of oxygen modulation therapy during treatment. Our interest in the postsurgical radiation field relates to the clinical need to understand whether the temporal dynamics of oxygen within the postsurgical radiation field has the potential to enhance the effectiveness of adjuvant therapies, and to understand how changes in short and long term oxygenation within the postsurgical radiation field may facilitate diminishment of late side effects from surgery and/or radiotherapy.
Following enrollment in the study, each subject will receive an initial placement of one or more geographically separate injections of India ink into the tissue of interest (i.e., tumor and/or tumor bed and/or adjacent tissue) using the established procedures for the injection of the ink. The subject is expected to agree to periodic measurements of all injection sites (unless the ink injection has been surgically removed); the subject will be told to expect six or more visits for measurements during treatment, but must agree to have at least one measurement per injection site. Each measurement will typically consist of 3 ten minute consecutive periods during which the subject initially breathes room air, then 100% oxygen delivered through a non-rebreather face mask followed by a period breathing room air.
Patients will be evaluated during clinical and oximetry appointments with respect to the presence of any adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Intraoral Squamous Cell Carcinomas | Intraoral squamous cell carcinomas that are resected and receive adjuvant radiation therapy. These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), or in both instances. Patients whose tumor is within 5 mm of the surface will have injections of India ink into the tumor itself and measurements made in the tumor prior to surgery. Patients whose tumor is deeper than 5 mm of the surface could participate only in the measurements of the postsurgical radiation field. EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the postsurgical radiation field as appropriate. |
| |
| 2: Cutaneous Malignant Tumors | Patients with primary cutaneous malignant tumors (including but not limited to squamous cell carcinoma, basal cell carcinoma, or melanoma) whose tumor is within 5 mm of the surface and whose treatment plan includes surgical resection and/or postsurgical radiation therapy. These patients may receive a Carlo Erba Ink injection before surgical tumor resection, after tumor resection (in the postsurgical radiation field), in both the tumor and the postsurgical radiation field, or in the tumor prior to radiation therapy. EPR Oximetry measurements will be made in the tumor and/or, if applicable, over the course of radiation in the tumor or postsurgical radiation field as appropriate. |
| |
| 3: Breast Cancers | Breast cancer patients whose treatment plan includes surgical resection followed by radiation therapy. All patients who receive a surgical resection will receive a Carlo Erba Ink injection in the radiation field after sufficient healing has occurred to the area to be injected, as determined in consultation with the treating physicians, and using topical anesthetic or local anesthetic, if the patient so desires. All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carlo Erba Ink Injection | Device | Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen. Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink. The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue. Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent. Carlo Erba is the name of the manufacturer that supplies the charcoal. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of oxygen levels in tissues in response to hyperoxic therapy | This study will assess whether the addition of hyperoxic therapy (100% oxygen delivered through a non-rebreather face mask) will increase the oxygen level of a tumor or tumor bed by > 5 mm Hg using EPR oximetry. Tumor oxygen values will be reported in millimeters of mercury (mmHg). | From time of ink injection to the time the ink is removed through surgical resection. This can range from days to years, or until the study's completion of enrollment, anticipated in 2020. |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize oxygen changes in tumor beds throughout the course of radiation therapy | This outcome will measure oxygen in the post-surgical tissue throughout the course of radiation therapy using EPR oximetry. Tissue oxygen values will be reported in millimeters of mercury (mmHg). | From time of ink injection through the completion of radiation therapy; an average of 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Histology | For those subjects whose tumor is resected along with the tissue containing the India ink carbon particles as a part of their usual care, the tissue at the site of the injection will be submitted for processing with standard pathology procedures. Tissue sections spanning the injection site(s) will be evaluated for the extent and mechanism of dispersion and for the presence of acute or chronic inflammation or other tissue reaction (scar, fibrosis, capsule formation, or other). The tissue will be assessed as to whether the reaction observed is as expected for ink injections. |
Inclusion Criteria:
Subject must be capable of giving informed consent or has an acceptable surrogate capable of giving consent on behalf of the subject.
Subject has an eligible tumor that is within 5 mm of the surface (either skin or mucosa) or has had a tumor removed with a tumor bed that is within 5 mm of the surface.
Eligible tumors types:
Exclusion Criteria:
Note: There is no known harm to the woman or her fetus from participating; this is precautionary only.
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Cancer patients with eligible tumors within 5mm of the surface, or that will be receiving postsurgical radiation following the resection of eligible tumors.
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| Name | Affiliation | Role |
|---|---|---|
| Philip E Schaner, M.D., Ph.D. | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03766 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8259056 | Background | Bacic G, Liu KJ, O'Hara JA, Harris RD, Szybinski K, Goda F, Swartz HM. Oxygen tension in a murine tumor: a combined EPR and MRI study. Magn Reson Med. 1993 Nov;30(5):568-72. doi: 10.1002/mrm.1910300507. | |
| 12465107 | Background | Baudelet C, Gallez B. How does blood oxygen level-dependent (BOLD) contrast correlate with oxygen partial pressure (pO2) inside tumors? Magn Reson Med. 2002 Dec;48(6):980-6. doi: 10.1002/mrm.10318. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D002280 | Carcinoma, Basal Cell |
| D002294 | Carcinoma, Squamous Cell |
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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If the India ink tattoo site is surgically excised as part of standard care for the treatment of the tumor, molecular tests may be performed on the excised tissue surrounding the ink injection site to analyze for molecular biomarkers related to hypoxia, angiogenesis, and tumor growth. The tissue analysis will explore the potential for any identifying biomarkers of the tumor that predict or otherwise are associated with variation in tumor growth or responsiveness to therapy. Subjects may choose to opt of this portion of the study.
|
| 4: Other tumors | Other tumors within 5 mm of the surface, whose planned treatment includes radiotherapy of the tumor and does not include a planned resection of the tumor. As these other qualifying malignancies are expected to occur only rarely, they will be grouped into a single cohort despite potential varied histology. These patients will receive a Carlo Erba Ink injection in their tumor prior to radiation therapy. All patients in this cohort will be expected to agree to a minimum of one EPR Oximetry measurement in the planned radiation field prior to radiation and a minimum of one measurement made over the course of radiation therapy. |
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| EPR Oximetry Measurement | Other | An oximetry measurement visit consists of ~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry. Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air. EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes. The minimum number of visits depends on the patient's cohort; all may have additional measurements. If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely. |
|
|
| Characterize oxygen changes in tumors throughout the course of radiation therapy | This outcome will measure tumor tissue oxygen throughout the course of radiation therapy using EPR oximetry. Tissue oxygen values will be reported in millimeters of mercury (mmHg). | From time of ink injection through the completion of radiation therapy; an average of 4 months. |
| Characterize oxygen changes in tumor and tumor beds prior to radiation therapy | For those subjects receiving India ink injections in both the untreated tumor and in the post-surgical bed prior to radiation, we will examine patterns across these two 'states' in individual tumors, which can enhance our understanding of the relationship between the oxygen levels in the tumor and in the resulting tumor bed. Tissue oxygen values will be reported in millimeters of mercury (mmHg). | From time of ink injection through the completion of medical treatment for cancer; an average of 4 months. |
| Characterize oxygen changes in tumor and tumor beds through the course of radiation therapy | For those subjects receiving India ink injections in both the untreated tumor and in the post-surgical bed while undergoing radiation therapy, we will examine patterns across these two 'states' in individual tumors, which can enhance our understanding of the relationship between the oxygen levels in the tumor and in the resulting tumor bed. Tissue oxygen values will be reported in millimeters of mercury (mmHg). | From time of ink injection through the completion of medical treatment for cancer; an average of 6 months. |
| Approximately 30 days post-surgical excision of the tumor |
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| 15680282 | Background | Khan N, Grinberg O, Wilmot C, Kiefer H, Swartz HM. "Distant spin trapping": a method for expanding the availability of spin trapping measurements. J Biochem Biophys Methods. 2005 Feb 28;62(2):125-30. doi: 10.1016/j.jbbm.2004.10.001. Epub 2004 Nov 13. |
| 15366033 | Background | Swartz HM, Khan N, Buckey J, Comi R, Gould L, Grinberg O, Hartford A, Hopf H, Hou H, Hug E, Iwasaki A, Lesniewski P, Salikhov I, Walczak T. Clinical applications of EPR: overview and perspectives. NMR Biomed. 2004 Aug;17(5):335-51. doi: 10.1002/nbm.911. |
| Background | Swartz, HM, N. Khan, B.B. Williams, A.C. Hartford, B. Zaki, M. Ernstoff, J.C. Buckey, F.F. Gubaidullin, H. Hou, P. Lesniewski, M. Kmiec, O.Y. Grinberg, A. Sucheta, and T. Walczak, Clinical Applications of In Vivo EPR: EPR Oximetry in Treasures of Eureka, Electron Paramagnetic Resonance From Fundamental Research To Pioneering Applications & Zavoisky Award, Volume 1, Axas Publishing, New Zealand, pp. 178-179 (2009). |
| 15607464 | Background | Swartz HM, Iwasaki A, Walczak T, Demidenko E, Salikov I, Lesniewski P, Starewicz P, Schauer D, Romanyukha A. Measurements of clinically significant doses of ionizing radiation using non-invasive in vivo EPR spectroscopy of teeth in situ. Appl Radiat Isot. 2005 Feb;62(2):293-9. doi: 10.1016/j.apradiso.2004.08.016. |
| 8133760 | Background | Swartz HM, Liu KJ, Goda F, Walczak T. India ink: a potential clinically applicable EPR oximetry probe. Magn Reson Med. 1994 Feb;31(2):229-32. doi: 10.1002/mrm.1910310218. |
| Background | Swartz, HM, R.P. Mason, N. Hogg, B. Kalyanaraman, T. Sarna, P.M. Plonka, M. Zareb, P.L. Gutierrez, and L.J. Berliner, Free Radicals and Medicine, in Biomedical ESR a volume in the Biological Magnetic Resonance Series (S.S. Eaton, G.R. Eaton, L.J. Berliner, eds.), Kluwer Publisher (The Netherlands, New York, Boston), Chapter 3, pp. 25-74 (2004a). |
| 24674520 | Background | Swartz HM, Williams BB, Jarvis LA, Zaki BI, Gladstone DJ. Repeated monitoring of tumor oxygen while breathing carbogen to determine the therapeutic potential of hyperoxic therapy. Pract Radiat Oncol. 2013 Apr-Jun;3(2 Suppl 1):S23-4. doi: 10.1016/j.prro.2013.01.084. Epub 2013 Mar 25. No abstract available. |
| 27526130 | Background | Swartz HM, Williams BB, Hou H, Khan N, Jarvis LA, Chen EY, Schaner PE, Ali A, Gallez B, Kuppusamy P, Flood AB. Direct and Repeated Clinical Measurements of pO2 for Enhancing Cancer Therapy and Other Applications. Adv Exp Med Biol. 2016;923:95-104. doi: 10.1007/978-3-319-38810-6_13. |
| 24439333 | Background | Swartz HM, Williams BB, Zaki BI, Hartford AC, Jarvis LA, Chen EY, Comi RJ, Ernstoff MS, Hou H, Khan N, Swarts SG, Flood AB, Kuppusamy P. Clinical EPR: unique opportunities and some challenges. Acad Radiol. 2014 Feb;21(2):197-206. doi: 10.1016/j.acra.2013.10.011. |
| 7045667 | Background | Tremper KK, Friedman AE, Levine EM, Lapin R, Camarillo D. The preoperative treatment of severely anemic patients with a perfluorochemical oxygen-transport fluid, Fluosol-DA. N Engl J Med. 1982 Jul 29;307(5):277-83. doi: 10.1056/NEJM198207293070503. |
| Background | Vaeth JM. Hyperbaric oxygen and radiation therapy of cancer. Frontiers of Radiation Therapy and Oncology. 1: 195 (1968). |
| 8133749 | Background | Vahidi N, Clarkson RB, Liu KJ, Norby SW, Wu M, Swartz HM. In vivo and in vitro EPR oximetry with fusinite: a new coal-derived, particulate EPR probe. Magn Reson Med. 1994 Feb;31(2):139-46. doi: 10.1002/mrm.1910310207. |
| 15254862 | Background | Vaupel P. Tumor microenvironmental physiology and its implications for radiation oncology. Semin Radiat Oncol. 2004 Jul;14(3):198-206. doi: 10.1016/j.semradonc.2004.04.008. |
| 17536958 | Background | Vaupel P, Hockel M, Mayer A. Detection and characterization of tumor hypoxia using pO2 histography. Antioxid Redox Signal. 2007 Aug;9(8):1221-35. doi: 10.1089/ars.2007.1628. |
| 20204785 | Background | Williams BB, Khan N, Zaki B, Hartford A, Ernstoff MS, Swartz HM. Clinical electron paramagnetic resonance (EPR) oximetry using India ink. Adv Exp Med Biol. 2010;662:149-56. doi: 10.1007/978-1-4419-1241-1_21. |
| D002277 |
| Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018295 | Neoplasms, Basal Cell |
| D018307 | Neoplasms, Squamous Cell |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |