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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01935 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 8118 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA155454 | U.S. NIH Grant/Contract | View source | |
| RG3114003 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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This trial studies magnetic resonance imaging (MRI) and positron emission tomography (PET) imaging in predictive treatment response in patients with stage IB-IVA cervical cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. PET is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Comparing results of diagnostic procedures, such as MRI and PET, done before, during and after radiation and chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
OUTLINE:
Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo dynamic contrast-enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and magnetic resonance (MR) spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and fludeoxyglucose F 18 (FDG) PET/computed tomography (CT) at baseline, 2-2.5 weeks, and 4-5 weeks.
After completion of study, patients are followed up at least every 3-6 months for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (DCE MRI, DW MRI, MR spectroscopy, FDG PET/CT) | Patients undergo radiation therapy and receive chemotherapy per standard of care. Patients undergo DCE MRI, DW MRI, and MR spectroscopy at baseline, 2-2.5 weeks, 4-5 weeks, and 1 month following radiation therapy completion, and FDG PET/CT at baseline, 2-2.5 weeks, and 4-5 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo FDG PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | Up to 5 years | |
| Distant metastatic rate | Up to 5 years | |
| Local control | Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings. | Up to 5 years |
| Predictive power of the MRI and PET/CT parameters | Hazard ratios will be calculated. Predictive power of the heterogeneity metrics will be compared and ranked with Federation of Gynecology and Obstetrics stage, lymph node status, histology, hemoglobin level, and tumor anatomic volumes. Multivariate predictive algorithms will be derived by synergizing the predictive power of imaging metrics and clinical prognosticators for clinical translation. | Up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, who will undergo radiation therapy for cervical cancer with curative intent.
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| Name | Affiliation | Role |
|---|---|---|
| Simon Lo | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States | ||
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| Diffusion Weighted Imaging | Procedure | Undergo DW MRI |
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| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | Undergo DCE MRI |
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| Fludeoxyglucose F-18 | Radiation | Undergo FDG PET/CT |
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| Magnetic Resonance Spectroscopic Imaging | Procedure | Undergo MR spectroscopy |
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| Positron Emission Tomography | Procedure | Undergo FDG PET/CT |
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| Loyola University Medical Center |
| Maywood |
| Illinois |
| 60153 |
| United States |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| University of Toronto | Toronto | Ontario | M5S 1A1 | Canada |
| University of Hong Kong | Hong Kong | Hong Kong |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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