Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer
This study is currently recruiting participants.
Verified December 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01613521
First received: June 5, 2012
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
This study is to assess how patients respond to their treatment for cervical cancer. This research does not involve a specific treatment for the cancer that will be recommended by the doctor and may include radiation therapy and/or chemotherapy. This is a separate research imaging study designed to assess how patients respond to their treatment for cervical cancer.
| Condition | Intervention |
|---|---|
|
Cervical Cancer |
Other: DCE-MRI and 18F-FMISO PET |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- predict tumor response [ Time Frame: 2 years ] [ Designated as safety issue: No ]For each DCE-MRI parameter, the relative percent change from baseline to the two-week measurement will be calculated. These values will be assessed using ROC curves to evaluate whether they are predictive of tumor response.
Secondary Outcome Measures:
- predict disease-free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]baseline tumor perfusion parameters are predictive of disease-free survival at 2 years and 5 years, the primary analysis will again be an ROC analysis, but with the ROC curves modified to take into account the censored failure-outcome. We will create time-dependent ROC curves using methods described by Heagerty et al.
| Estimated Enrollment: | 50 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DCE-MRI and 18F-FMISO PET
Each patient will undergo three DCE-MRI (dynamic contrast-enhanced MRI) studies: a baseline DCE-MRI within two weeks before chemoradiation; a second DCE-MRI after the second week of treatment (within a week); and a third DCE-MRI three months after treatment. As a pilot study in 10 patients, we will perform 18F-FMISO PET/CT on the same day of a baseline DCE-MRI before chemoradiation. Treatment decisions will not be based on DCE-MRI and 18F-FMISO PET/CT studies.
|
Other: DCE-MRI and 18F-FMISO PET
DCE-MRIs: (i) Baseline DCE-MRI within two weeks before chemoradiation; (ii) Second DCE-MRI after the second week of chemoradiation (within a week); (iii) Third DCE-MRI three months after chemoradiation. iii. 18F-FMISO PET: Baseline 18F-FMISO PET within two weeks before chemoradiation (only 10 patients as a pilot study). iv. Clinical Follow-up: (i) Physical examination (every 3 months); (ii) Pap smear or cervical biopsy (every 3 months); (iii) follow-up imaging studies (CT and/or MRI) as per routine clinical follow-up of patients.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology types.
- Clinically visible gross lesion (International Federation of Gynecology and Obstetrics (FIGO) stage IB1 and above).
- Treatment (chemoradiation), DCE-MRI and 18F-FMISO PET studies will be at MSKCC.
- Patients must be an adult female 18 years of age or older.
Exclusion Criteria:
- Patients who because of general medical or psychiatric condition, or physiologic status cannot give an informed consent.
- Patients who received prior radiation treatment to pelvis.
- Patients with contraindications to DCE-MRI (non-compatible cardiac pacemakers or intracranial vascular clips, allergy to Gadolinium, end-stage renal disease) and/or 18F-FMISO PET.
- Patients who do not fulfill the screening criteria for safe DCE-MRI or 18F-FMISO PET as per the Department of Radiology guidelines.
- Pregnant patients; and or patients who are breast-feeding their babies.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613521
Contacts
| Contact: Oguz Akin, MD | 212-639-3458 | |
| Contact: Kaled Alektiar, MD | 212-639-7981 |
Locations
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Oguz Akin, MD 212-639-3458 | |
| Contact: Kaled Alektiar, MD 212-639-7981 | |
| Principal Investigator: Oguz Akin, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
| Principal Investigator: | Oguz Akin, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01613521 History of Changes |
| Other Study ID Numbers: | 11-174 |
| Study First Received: | June 5, 2012 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
DCE-MRI 18F-FMISO PET 11-174 |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Anoxia Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases |
Uterine Diseases Genital Diseases, Female Signs and Symptoms, Respiratory Signs and Symptoms Fluoromisonidazole Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013