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This pilot study will determine changes over time in tumor volume/motion & patient anatomy, as well as dose distributions to normal organs. The study will inform medical decision-making about need for (and timing of) re-calibration of radiation dosimetry plans. Weekly CT and/or serial MR scans will be employed for those patients receiving 7-8 wks of radiation therapy. The study will enroll 30 patients in each stratum: Non small cell lung cancer (NSCLC), Head & Neck, gastrointestinal (GI) and Gynecologic tumor.
This is a pilot study to estimate the degree of tumor volume, tumor motion and patient anatomy change during treatment with photon or proton beam radiotherapy. Patients will undergo simulation with an MR scan and/or CT scan per best clinical practices, and 4D imaging will be employed as indicated, at the discretion of the treating radiation oncologist. Photon beam treatment plans and Proton beam treatment plans will be generated from these images. Based on the location of the primary tumor, patients will undergo either up to weekly 3D or 4D CT and/or serial MR scans during treatment. These images will be compared to the initial CT/MR scans used for treatment planning and analyzed for changes in tumor volume and tumor anatomic location. At the end of treatment, the frequent 3D or 4D CT and/or serial MR images will be compared to the initial treatment planning images to quantify the changes in tumor volume and tumor motion during the course of radiation treatment. Each CT and/or MR Scan will also be used to evaluate the changes in dose distribution to the target volumes and normal tissues that occur with the initial photon treatment plan and initial proton treatment. The changes in tumor volume, tumor motion and dose distribution during the course of radiation treatment will be analyzed to determine the effect of tumor changes on radiation treatment efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lung Imaging | Other | Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT scan | Diagnostic Test | Weekly 3D/4D CT scan |
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| Measure | Description | Time Frame |
|---|---|---|
| Tumor Volume | The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging. | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
- Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Wei Zou, PhD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Imaging | Weekly 3D/4D CT scans while receiving radiation therapy. Radiation therapy dosage metrics were not collected. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 18, 2013 |
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Pilot study
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| COMPLETED |
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| NOT COMPLETED |
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Only 44 Patients had interpretable GTV baseline measures from imaging
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| ID | Title | Description |
|---|---|---|
| BG000 | Imaging | Weekly 3D/4D CT scans; MRI scans used at the discretion of the treating physician when the location of the tumor requires it. |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Tumor volume | Mean | Standard Deviation | cm^3 |
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| 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 | Tumor Volume | The degree of tumor volume, tumor motion and patient anatomy change during treatment with photon beam radiotherapy using 4D or 3D CT Scans and/or a serial of MR Imaging. | Posted | Mean | Standard Deviation | cm^3 | 9 weeks |
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Adverse events were not collected for this imaging trial.
Adverse events were not collected for this imaging trial as they would not be relevant to the purposes of the trial (to track change in GTV over time via CT scans).
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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 | Complete Imaging | Weekly 3D/4D CT scans during radiation therapy. MRI may be used in addition to or instead of CT depending on the location of the tumor and the decision of the treating physician. CT scan: Weekly 3D/4D CT scan | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wei Zou | University of Pennsylvania | 800-789-7366 | Wei.Zou@pennmedicine.upenn.edu |
| Apr 9, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| ID | Term |
|---|---|
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D014054 | Tomography |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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