FLT PET Imaging for Cervical Cancer

University of Iowa

Status and phase

Terminated

Phase 2

Conditions

Uterine Cervical Neoplasms

Treatments

Drug: [F18]Fluorothymidine

Study type

Interventional

Funder types

Other

Identifiers

NCT01075412

200906786

Details and patient eligibility

About

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.

Full description

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.

Enrollment

6 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.