Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this study is to learn if the intervention using a fluorescent agent 5-Aminolevulinic acid (5-ALA) to aid in the surgical approach to visualize the soft-tissue sarcoma (STS) during surgical resection. 5-ALA goes through the blood stream and into the tumor tissue allowing it to light up when the surgeon uses a special light in the operating room. The technique is called 5-ALA fluorescence-guided surgery (FGS). The main question aims to answer if 5-ALA provide intraoperative fluorescent visualization of soft-tissue sarcoma versus surrounding tissue and demonstrate the efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal. Participants will be asked to orally administer 5-ALA three to four hours prior to surgery in preoperative area.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patients diagnosed with Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) Grade 2 or 3 soft tissue sarcomas who undergo surgical resection will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to anesthesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ALA | Drug | 5-ALA), also known by its brand name Gleolan, is an intermediate in the heme synthesis pathway that has been studied in tumor resections, especially in intracranial tumor resections. One advantage of intraoperative visualization with 5-ALA is the ability to directly visualize fluorescent tumor in the surgical field using a headset-mounted devices with fluorescence in the visual wavelength in real-time. |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the feasibility of 5-ALA aided fluorescent visualization of soft tissue sarcomas versus surrounding tissues | Patients will receive 5-ALA administered in the preoperative area. Surgical resection of the soft tissue sarcoma will be done as per standard of care. A fluorescent headset will be turned on at defined time points below and tumor fluorescence will be noted (yes or no):
| From enrollment to 2 weeks |
| Surgeon survey results of intraoperative tumor fluorescence | Surgeons will fill out survey (yes or no) to answer following intraoperative assessment questions:
| perioperative/periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of non-fluorescing samples after tumor removal | The sarcoma tumor will then be hemisected immediately after resection in pathology lab. The fluorescent headset will be used to identify areas of fluorescence in the tumor. Multiple samples (3mm punch) will be taken from nonfluorescent areas and placed on slides: Histologic analysis will evaluate for viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence. |
Not provided
Inclusion Criteria:
Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC).
Treatment decision includes planned surgical resection of STS.
Age ≥18 years at time of consent.
ECOG Performance Status 0 - 1.
Hematology and blood chemistry parameters defined by:
Participants of reproductive potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 42 days after end of study intervention; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy).
Ability to swallow study agent.
Ability to understand and willingness to sign an informed consent form.
Ability and stated willingness to adhere to the study visit schedule and other protocol procedures/requirements for the duration of the study.
Inclusion of Minorities and Other Underrepresented Populations Recruitment is open and encouraged to all genders, all minorities, and underrepresented populations. Although distributions may vary by disease type, our recruitment procedures have been developed to enroll participants who are representative of the respective target population.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregory Ottenberg | Contact | 303-724-0875 | gregory.ottenberg@cuanschutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Steven Thorpe, MD, FACS | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26885645 | Result | Teixidor P, Arraez MA, Villalba G, Garcia R, Tardaguila M, Gonzalez JJ, Rimbau J, Vidal X, Montane E. Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study. PLoS One. 2016 Feb 17;11(2):e0149244. doi: 10.1371/journal.pone.0149244. eCollection 2016. | |
| 36656388 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Day of Surgery |
| Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal | Description: The sarcoma tumor will then be hemisected immediately after resection in pathology lab. The fluorescent headset will be used to identify areas of fluorescence in the tumor. Multiple samples (3mm punch) will be taken from these fluorescent areas in the tumor and placed on slides: Specific to the margins and include the relevant presence of fluorescence (yes/no), cancer cells(%). For this, Sensitivity will be considered as the proportion of cancerous cells that fluoresced, with specificity as the proportion of non-cancerous cells that did not. | Day of surgery |
| Demonstrate the efficacy of 5-ALA fluorescence in tumor resections by a histological analysis of fluorescing samples after tumor removal | The sarcoma tumor will then be hemisected immediately after resection in pathology lab. The fluorescent headset will be used to identify areas of fluorescence in the tumor. Multiple samples (3mm punch) will be taken from these fluorescent areas in the tumor and placed on slides: These will be specific to the tumor and include the relevant presence of fluorescence (yes/no), viable tumor cells (%). For this, Sensitivity will be considered as the proportion of cells who had viable tumor that fluoresced, with specificity as the proportion of cells that had non-viable tumor without fluorescence. | Day of surgery |
| Determine oncologic outcomes for patients enrolled | Local recurrence free survival will be determined from time of surgery and with use of MRI with contrast | From enrollment to 2 years |
| Patient Reported Outcomes | Patient Reported Outcomes Measurement Information System (PROMIS) patient reported outcome measure. | From enrollment to 2 years |
| Patient Reported Outcomes | Toronto Extremity Salvage Score (TESS) patient reported outcome measure. | From enrollment to 2 years. |
| Patient Reported Outcomes | Visual Analog Scales (VAS) patient reported outcome measure. | From enrollment to 2 years. |
| Giantini-Larsen AM, Kharas N, Pisapia D, Schwartz TH. Histology of high-grade glioma samples resected using 5-ALA fluorescent headlight and loupe combination. Acta Neurochir (Wien). 2023 Feb;165(2):567-575. doi: 10.1007/s00701-023-05496-8. Epub 2023 Jan 19. |
| 16648043 | Result | Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9. |
| 34624862 | Result | Schupper AJ, Baron RB, Cheung W, Rodriguez J, Kalkanis SN, Chohan MO, Andersen BJ, Chamoun R, Nahed BV, Zacharia BE, Kennedy J, Moulding HD, Zucker L, Chicoine MR, Olson JJ, Jensen RL, Sherman JH, Zhang X, Price G, Fowkes M, Germano IM, Carter BS, Hadjipanayis CG, Yong RL. 5-Aminolevulinic acid for enhanced surgical visualization of high-grade gliomas: a prospective, multicenter study. J Neurosurg. 2021 Oct 8;136(6):1525-1534. doi: 10.3171/2021.5.JNS21310. Print 2022 Jun 1. |
| 30659522 | Result | Mahmoudi K, Garvey KL, Bouras A, Cramer G, Stepp H, Jesu Raj JG, Bozec D, Busch TM, Hadjipanayis CG. 5-aminolevulinic acid photodynamic therapy for the treatment of high-grade gliomas. J Neurooncol. 2019 Feb;141(3):595-607. doi: 10.1007/s11060-019-03103-4. Epub 2019 Jan 18. |
| 35033148 | Result | Guder WK, Hartmann W, Buhles C, Burdack M, Busch M, Dunker N, Hardes J, Dirksen U, Bauer S, Streitburger A. 5-ALA-mediated fluorescence of musculoskeletal tumors in a chick chorio-allantoic membrane model: preclinical in vivo qualification analysis as a fluorescence-guided surgery agent in Orthopedic Oncology. J Orthop Surg Res. 2022 Jan 15;17(1):34. doi: 10.1186/s13018-022-02931-x. |
| 32138774 | Result | Kenan S, Liang H, Goodman HJ, Jacobs AJ, Chan A, Grande DA, Levin AS. 5-Aminolevulinic acid tumor paint and photodynamic therapy for myxofibrosarcoma: an in vitro study. J Orthop Surg Res. 2020 Mar 5;15(1):94. doi: 10.1186/s13018-020-01606-9. |
| 30173528 | Result | Endo M, Lin PP. Surgical margins in the management of extremity soft tissue sarcoma. Chin Clin Oncol. 2018 Aug;7(4):37. doi: 10.21037/cco.2018.08.10. |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |