Clinical trial · Interventional
FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.
Conditions
Conditions (8)
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 Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IVA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-fluoromisonidazole | Other | — | UNRESOLVED |
| fluorodeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
| tissue oxygen measurement | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic FMISO AND FDG PET
- description
- Patients receive \^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second \^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior \^18F FDG PET scan as part of their routine clinical management undergo \^18F FDG PET scanning at baseline.
- interventionNames
- Other: 18F-fluoromisonidazole
- Radiation: fluorodeoxyglucose F 18
- Procedure: positron emission tomography
- Other: tissue oxygen measurement
Primary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- For up to 2 years
- description
- Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.
- measure
- Disease-free Survival (DFS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix * Clinical stage IB-IVB by FIGO criteria * Size of the primary tumor ≥ 2 cm as assessed by CT scan * Measurable disease * Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management * No prior cervical cancer diagnosis * No known brain metastases * ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%) * Life expectancy \> 12 months * Not pregnant * No nursing for 24 hours after fluoromisonidazole F 18 (\[\^18F\] FMISO) PET scanning * Negative pregnancy test * Weight ≤ 400 lbs * Sufficiently healthy to undergo cancer treatment * Willing to undergo PET scanning with urinary bladder catheterization * Leukocytes ≥ 3,000/mm³ * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Total bilirubin normal * AST/ALT ≤ 2.5 times normal * Creatinine normal OR creatinine clearance ≥ 60 mL/min * No serious medical co-morbidities that would preclude definitive local therapy * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to \[\^18F\] FMISO * No concurrent uncontrolled illness including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements. * No prior surgery or radiotherapy for cervical cancer * Other concurrent investigational agents allowed
References
Publications (0)
Data not yet available