Trial record 1 of 1 for:
NCT01992861
MRI and PET Imaging in Predicting Treatment Response in Patients With Stage IB-IVA Cervical Cancer
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| ClinicalTrials.gov Identifier: NCT01992861 |
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Recruitment Status :
Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : October 6, 2022
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Sponsor:
University of Washington
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Washington
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Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Cervical Adenocarcinoma Cervical Adenosquamous Carcinoma Cervical Squamous Cell Carcinoma, Not Otherwise Specified Cervical Undifferentiated Carcinoma Recurrent Cervical Carcinoma Stage IB2 Cervical Cancer Stage II Cervical Cancer Stage IIA Cervical Cancer Stage IIB Cervical Cancer Stage III Cervical Cancer Stage IIIA Cervical Cancer Stage IIIB Cervical Cancer Stage IVA Cervical Cancer | Procedure: Computed Tomography Procedure: Diffusion Weighted Imaging Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Radiation: Fludeoxyglucose F-18 Procedure: Magnetic Resonance Spectroscopic Imaging Procedure: Positron Emission Tomography |
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.
| Study Type : | Observational |
| Actual Enrollment : | 32 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix |
| Study Start Date : | February 14, 2014 |
| Estimated Primary Completion Date : | September 1, 2023 |
| Estimated Study Completion Date : | September 1, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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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Procedure: Computed Tomography
Undergo FDG PET/CT
Other Names:
Procedure: Diffusion Weighted Imaging Undergo DW MRI
Other Names:
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Undergo DCE MRI
Other Names:
Radiation: Fludeoxyglucose F-18 Undergo FDG PET/CT
Other Names:
Procedure: Magnetic Resonance Spectroscopic Imaging Undergo MR spectroscopy
Other Names:
Procedure: Positron Emission Tomography Undergo FDG PET/CT
Other Names:
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Primary Outcome Measures :
- Disease-free survival [ Time Frame: Up to 5 years ]
- Distant metastatic rate [ Time Frame: Up to 5 years ]
- Local control [ Time Frame: Up to 5 years ]Clinical/pelvic examination, pap smear, other standard of care investigations as indicated by clinical findings.
- Predictive power of the MRI and PET/CT parameters [ Time Frame: Up to 5 years ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
- Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
- Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
- Patients with no prior radiation therapy to the pelvis
- Patients with no contra-indications to magnetic resonance (MR) imaging
- Patients must have adequate renal function: glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2; for the test-retest sub-study MRI, patients must have a GFR of > 60 mL/min/1.73m^2
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients with small cell/neuroendocrine cervical carcinoma
- Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
- Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)
- Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
- Life expectancy of less than 6 months
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992861
Locations
| United States, Florida | |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | |
| Miami, Florida, United States, 33136 | |
| United States, Illinois | |
| Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| United States, Ohio | |
| Ohio State University Comprehensive Cancer Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Washington | |
| Fred Hutch/University of Washington Cancer Consortium | |
| Seattle, Washington, United States, 98109 | |
| Canada, Ontario | |
| University of Toronto | |
| Toronto, Ontario, Canada, M5S 1A1 | |
| Hong Kong | |
| University of Hong Kong | |
| Hong Kong, Hong Kong | |
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
| Principal Investigator: | Simon Lo | Fred Hutch/University of Washington Cancer Consortium |
| Responsible Party: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT01992861 |
| Other Study ID Numbers: |
8118 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 ) RG3114003 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) |
| First Posted: | November 25, 2013 Key Record Dates |
| Last Update Posted: | October 6, 2022 |
| Last Verified: | September 2022 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Uterine Cervical Neoplasms Carcinoma, Adenosquamous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Neoplasms, Complex and Mixed Deoxyglucose Fluorodeoxyglucose F18 Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action Antimetabolites Antiviral Agents Anti-Infective Agents |