Overview

This trial is active, not recruiting.

Condition uterine cervical neoplasms
Treatment [f18]fluorothymidine
Phase phase 2
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
[f18]fluorothymidine FLT
FLT PET scan 5 mCi (+/- 10%)
(Experimental)
Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.
[f18]fluorothymidine FLT
FLT PET scan 5 mCi (+/- 10%)

Primary Outcomes

Measure
FLT uptake
time frame: baseline, weeks 1, 2, 3, and 4 of therapy, and 1 month post-therapy
Prognostic outcome
time frame: Post-treatment

Secondary Outcomes

Measure
Bone marrow
time frame: pre-treatment
Biomarkers
time frame: Weekly during treatment
Compliance
time frame: post-treatment

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Iowa.