Cervical Cancer
Conditions
Keywords
DCE-MRI, 18F-FMISO PET, 11-174
Brief summary
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.
Interventions
OTHERDCE-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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| predict tumor response | 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| predict disease-free survival | 2 years | 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. |
Countries
United States
Outcome results
None listed