Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: 64Cu-ATSM; FDG
Intervention MeSH terms: Fluorodeoxyglucose F18
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cervical squamous cell carcinoma; stage IIB cervical cancer; stage III cervical cancer; stage IV cervical cancer; stage IVA cervical cancer; stage IB cervical cancer; stage IIA cervical cancer

Summary:

      RATIONALE: Diagnostic procedures, such as 64Cu-labeled
      diacetyl-bis[N4-methylthiosemicarbazone] (copper Cu 64-ATSM) PET/CT scans, may help doctors
      predict how patients will respond to treatment.

      PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in
      predicting disease progression in patients undergoing standard of care treatment with
      cisplatin and radiation therapy (external beam and brachytherapy) per National Comprehensive
      Cancer Network (NCCN) guidelines for newly-diagnosed stage IB, stage II, stage III, or stage
      IVA cervical cancer via the Federation of Gynecology and Obstetrics (FIGO) staging systems.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed primary invasive cervical squamous cell carcinoma

               -  Newly diagnosed disease

               -  Stage IB2 - IVA disease based on FIGO staging system

          -  Plan to receive standard of care treatment with concurrent cisplatin and radiation
             therapy (external beam and brachytherapy) per NCCN guidelines

               -  Must be scheduled to receive 6 weekly courses of cisplatin

          -  Meets 1 of the following criteria:

               -  Pelvic nodal (or no nodal) disease only by FDG-PET/CT scan within 4 weeks of
                  enrollment

               -  Para-aortic nodal metastasis by FDG-PET/CT scan within 4 weeks of enrollment, and
                  patient will undergo radiotherapy to para-aortic nodes

               -  FDG-PET/CT scan at baseline if not meeting any of the above criteria

          -  No stage IVB disease (distant metastases or supraclavicular metastasis) confirmed by
             FDG-PET/CT scan

          -  No recurrent invasive carcinoma of the uterine cervix regardless of previous treatment

          -  No know metastases to lungs, supraclavicular lymph nodes, or other organs outside of
             the pelvis or abdominal lymph nodes at time of diagnosis

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to lie flat for the duration of the PET/CT scan

          -  No septicemia or severe infection

          -  No uncontrolled or poorly controlled diabetes

          -  No circumstances that would prevent completion of imaging studies or required clinical
             follow-up

          -  No other prior or concurrent invasive malignancies, with the exception of non-melanoma
             skin cancer, within the past 5 years

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior pelvic or abdominal lymphadenectomy

          -  No prior pelvic radiation therapy

          -  No previous cancer treatment contraindicates this protocol therapy