FLT PET Imaging for Cervical Cancer
| Status: | Terminated |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Women's Studies |
| Therapuetic Areas: | Oncology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/3/2017 |
| Start Date: | September 2009 |
| End Date: | April 11, 2016 |
`F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
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.
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.
Subjects will undergo a total of up to 5 FLT PET scans.
Subjects are randomized between two groups to reduce radiation exposure from the FLT PET
scans. If bone marrow activity is not identified in one scan, further scans are cancelled
until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy
between two study arms. Data will be pooled for analysis as pre-specified in the study's
statistical plan.
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.
Subjects are randomized between two groups to reduce radiation exposure from the FLT PET
scans. If bone marrow activity is not identified in one scan, further scans are cancelled
until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy
between two study arms. Data will be pooled for analysis as pre-specified in the study's
statistical plan.
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.
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.
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