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| ID | Type | Description | Link |
|---|---|---|---|
| HUM 757 | Other Identifier | University of Michigan IRBMED |
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Cone beam CT (computed tomography) is a developing technology which allows CT images to be obtained while a patient is on the radiation treatment table.(A CT scan uses x-rays to produce detailed pictures of structures in the body.) In this study, cone beam CT scans will be obtained before individual radiation treatment sessions for head and neck cancer. The information gathered from these scans will be used by the researchers to look at patient movement as well as changes in the amount of normal and tumor tissue throughout the course of radiation therapy. The researchers will use this information to create hypothetical radiation treatment plans, which will be used as the basis for future research. The cone beam CT scan data will not be used to alter the actual radiation treatment of any of the patients enrolled on the study. In addition, tests of salivary output and swallowing and questionnaires about quality of life will be made to assess how the doses of radiation affect them.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cone Beam CT | Experimental | All patients will be included in the treatment arm of this study. For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Although the exact amount of radiation patients get will be determined by their doctor, it is expected that they will get approximately 7 weeks, approximately 35 total cone beam CT scans. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cone Beam Computed Tomography (CT) Scan | Other | Cone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body). It will add a small amount of additional radiation dose (less than 1%) to the head and neck. The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive. The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Movement of Normal Tissue | The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement. | approximately 7 weeks |
| Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months). | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Image Quality | Use acquired data to further improve cone beam CT reconstruction techniques and image quality. | 36 months |
| The Median Delivered Dose of Radiation to the Parotid Gland |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avraham Eisbruch, MD | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24035328 | Result | Hunter KU, Fernandes LL, Vineberg KA, McShan D, Antonuk AE, Cornwall C, Feng M, Schipper MJ, Balter JM, Eisbruch A. Parotid glands dose-effect relationships based on their actually delivered doses: implications for adaptive replanning in radiation therapy of head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2013 Nov 15;87(4):676-82. doi: 10.1016/j.ijrobp.2013.07.040. Epub 2013 Sep 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cone Beam CT | For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Radiotherapy will be delivered according to current guidelines. Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Although 23 patients were enrolled, only 18 completed treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cone Beam CT | For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Radiotherapy will be delivered according to current guidelines. Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Movement of Normal Tissue | The primary outcome measure of this study is to characterize patient-specific target and normal tissue movement. | Not Posted | approximately 7 weeks | ||||||||||||
| Secondary | Improvement of Image Quality | Use acquired data to further improve cone beam CT reconstruction techniques and image quality. | Not Posted | 36 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cone Beam CT | For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently). Radiotherapy will be delivered according to current guidelines. Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalemia | Metabolism and nutrition disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chemoradiation Rash | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Avraham Eisbruch, M.D. | University of Michigan Comprehensive Cancer Center | 734-936-4302 | eisbruch@umich.edu |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 7 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Disease Site | Location of the disease at baseline. | Number | participants |
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| T Stage | The T stage represents the size and stage of the primary tumor: TX: Primary tumor cannot be evaluated T0: No evidence of primary tumor Tis: Carcinoma in situ (CIS; abnormal cells are present but have not spread to neighboring tissue; although not cancer, CIS may become cancer and is sometimes called preinvasive cancer) T1, T2, T3, T4: Size and/or extent of the primary tumor (higher numbers represent more extensive disease) | Number | participants |
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| N Stage | The N stage represents the amount of spread to nearby lymph nodes: NX: Regional lymph nodes cannot be evaluated N0: No regional lymph node involvement N1, N2, N3: Degree of regional lymph node involvement (number and location of lymph nodes) | Number | participants |
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| Pre-Treatment Weight | Median | Full Range | lb |
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| Secondary | The Median Delivered Dose of Radiation to the Parotid Gland | Posted | Median | Full Range | Gy | 7 weeks |
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| Primary | Correlation Coefficient for the Association Between Delivered Mean Parotid Dose and Salivary Flow Rate | Spearman rank-based correlation coefficients were calculated for the association between saliva flow rate and the delivered mean parotid doses at several timepoints (Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months). | 36 parotid glands were evaluable from 18 patients at baseline, 34 parotid glands were evaluable at 3-6 months, 32 glands were evaluable at 12 months, 20 were evaluable at 18 months and 8 at 24 months. | Posted | Number | correlation coefficient | 24 months |
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| 2 |
| 18 |
| 9 |
| 18 |
| Renal Failure | Renal and urinary disorders |
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| Radiation Rash | Skin and subcutaneous tissue disorders |
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| Dehydration | Metabolism and nutrition disorders |
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| xerostomia | Gastrointestinal disorders |
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| Dysphagia | Gastrointestinal disorders |
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| Esophagitis | Gastrointestinal disorders |
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| Gastrointestinal Other | Gastrointestinal disorders |
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| Mucositis/Stomatitis (upon exam) | Investigations |
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| Mucositis/Stomatitis (symptomatic) | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Salivary Gland Changes | Gastrointestinal disorders |
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| Dysgeusia | Gastrointestinal disorders |
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| Title | Measurements |
|---|---|
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| 12 Months |
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| 18 Months |
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| 24 Months |
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