Clinical trial · Interventional
18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma
A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Soft Tissue Sarcoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding source ended earlier than anticipated
Summary
Brief summary (as posted)
This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage I Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage II Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage III Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Stage IV Adult Soft Tissue Sarcoma | Adult Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-fluoromisonidazole | Other | — | UNRESOLVED |
| computed tomography | Procedure | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| positron emission tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F FDG and 18F FMISO PET/CT)
- description
- Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.
- interventionNames
- Radiation: fludeoxyglucose F 18
- Other: 18F-fluoromisonidazole
- Procedure: positron emission tomography
- Procedure: computed tomography
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Changes From Baseline Hypoxic Volume (HV)
- timeFrame
- Baseline and up to 2 years
- description
- ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed intermediate- or high-grade soft tissue sarcoma * Biopsy proven or highly suspicious primary or recurrent disease * Tumor size ≥ 2 cm * Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy * Life expectancy ≥ 12 months * Negative pregnancy test * Willing to undergo PET scanning * Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors) * Able to lie on the imaging table for up to 1.5 hours * Weight ≤ 400 lbs * Not pregnant
References
Publications (0)
Data not yet available