Trials / Active Not Recruiting
Active Not RecruitingNCT03168737
18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients
Test-Retest of (18)F-Fluoroazomycin Arabinoside ([18F]FAZA) PET-CT of Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This early phase I trial studies how well 18F-fluoroazomycin arabinoside positron emission tomography (PET)-computed tomography (CT) works in diagnosing solid tumors. Using 18F-fluoroazomycin arabinoside with PET-CT may help doctors plan better treatment for patients with solid tumors. 18F-fluoroazomycin arabinoside may help to show how much oxygen is present in a tumor during a PET-CT scan.
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the feasibility of PET-CT using 18F-fluoroazomycin arabinoside (\[18F\]FAZA) and to determine the optimal imaging time to detect hypoxia in solid tumors. SECONDARY OBJECTIVES: I. To determine the variability of imaging findings from repeated \[18F\]FAZA PET-CT studies over \>= 24 hours up to 10 days. II. To confirm the safety of \[18F\]FAZA administered during PET-CT imaging of hypoxia of solid tumors. OUTLINE: Patients are assigned to 1 of 2 groups. GROUP A: Patients receive 18F-fluoroazomycin arabinoside intravenously (IV) and after 60 minutes undergo 5 PET-CT scans at 60, 90, 120, 150, and 180 minutes on days 1 and 2. GROUP B: Patients receive 18F-fluoroazomycin arabinoside IV and after 60 minutes undergo 5 or less PET-CT scans on day 1 and 5 or less PET-CT scans \>= 24 hours later up to 10 days. After completion of study treatment, patients are followed up at 24 hours and at 30 days.
Conditions
- Malignant Breast Neoplasm
- Malignant Colorectal Neoplasm
- Malignant Pancreatic Neoplasm
- Malignant Solid Neoplasm
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Computed Tomography | Undergo PET-CT scan |
| RADIATION | Fluorine F 18-fluoroazomycin Arabinoside | Given IV |
| PROCEDURE | Positron Emission Tomography | Undergo PET-CT scan |
Timeline
- Start date
- 2017-09-22
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
- First posted
- 2017-05-30
- Last updated
- 2026-04-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03168737. Inclusion in this directory is not an endorsement.