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`F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Uterine Cervical Neoplasms

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Trial Information

`F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

FLT uptake

Outcome Description:

Standarized uptake values of the FLT tracer signal in both the tumor volume and bone marrow volume. Changes in uptake will be assessed compared to treatment outcome as well as blood cell counts.

Outcome Time Frame:

baseline, weeks 1, 2, 3, and 4 of therapy, and 1 month post-therapy

Safety Issue:

Yes

Principal Investigator

Michael M Graham, Ph.D., M.D.

Investigator Role:

Study Director

Investigator Affiliation:

The University of Iowa

Authority:

United States: Food and Drug Administration

Study ID:

200906786

NCT ID:

NCT01075412

Start Date:

September 2009

Completion Date:

September 2016

Related Keywords:

  • Uterine Cervical Neoplasms
  • Positron-Emission Tomography
  • Radiotherapy, Intensity-Modulated
  • Neoplasms
  • Uterine Cervical Neoplasms

Name

Location

Holden Comprehensive Cancer CenterIowa City, Iowa  52242-1009