FLT PET Imaging for Cervical Cancer
This trial is active, not recruiting.
|Condition||uterine cervical neoplasms|
|Sponsor||University of Iowa|
|Collaborator||Holden Comprehensive Cancer Center|
|Start date||September 2009|
|End date||May 2016|
|Trial size||30 participants|
|Trial identifier||NCT01075412, 200906786|
Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor.
This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: baseline, weeks 1, 2, 3, and 4 of therapy, and 1 month post-therapy
time frame: Post-treatment
time frame: pre-treatment
time frame: Weekly during treatment
time frame: post-treatment
Female participants at least 18 years old.
Inclusion Criteria: - Ability to understand and willingness to sign a written informed consent document. - Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix. - Scheduled to receive chemo-radiation for oncologic treatment. - Karnofsky of at least 60 at time of screening - Life expectancy of at least 6 months. - Leukocytes at least 3,000/microL - absolute neutrophil count at least 1,500/microL - platelets at least 100,000/microL - total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal) - either ALT or AST less than 2.5 times the upper limit of normal - creatinine less than 1.5 times the upper limit of normal - non-pregnant, non-nursing, willing to use contraception Exclusion Criteria: - oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy - uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. - subjects taking nucleoside analog medications such as those used as antiretroviral agents. - patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.
|Official title||`F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer|
|Principal investigator||Sarah McGuire, Ph.D.|
|Description||Subjects will undergo a total of 5 FLT PET scans. Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy. Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.|
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