Clinical trial · Interventional
Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer
Copper Cu 64-ATSM and PET/CT Scan in Predicting Disease Progression in Patients With Newly-Diagnosed Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Undergoing Chemoradiotherapy Per NCCN Guidelines
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): transfer of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 64Cu-ATSM | Drug | — | UNRESOLVED |
| FDG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Copper ATSM
- description
- pre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT
- interventionNames
- Drug: 64Cu-ATSM
- Drug: FDG
Primary outcomes (1)
- measure
- Relationship Between Copper Cu 64-ATSM Uptake in the Primary Tumor and Progression-free Survival 3 Years After Chemoradiotherapy
- timeFrame
- every 3 months for first 2 years and every 6 months during year 3, up to 3 years
- description
- Progression-free survival (PFS) evaluated every 3 months for first 2 years and every 6 months during year 3 to determine PFS at 3years. Cu64-ATSM Uptake measured within 14 days of baseline Uptake is a measure of activity within a tumor 1. the maximum standardized uptake value (SUVmax = tracer uptake in ROI / (injected activity / patient weight)) 2. Tumor-to-Muscle uptake ratio (T/M, An FDG-PET/CT-guided circular region of interest of 1.0-1.5 cm in diameter is drawn around the most intense region of the primary tumor to calculate the maximum uptake within the region. In addition, regions of interest are drawn on bilateral gluteal muscle groups on at least 3 slices, and the mean uptake is calculated. The T/M is the ratio of these measurements.)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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