Clinical trial · Observational
A Radiopharmacokinetic and Radiodosimetric Phase I Imaging Study of 18F-FAZA
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Limited scanner availability
Summary
Brief summary (as posted)
Hypoxia (little of no oxygen) is considered to be an important characteristic of a patient's tumour that may help predict patient outcomes and/or help inform patient management decisions. 18F-FAZA Positron Emission Tomography (PET) can detect hypoxic tumours because 18F-FAZA accumulates in hypoxic tissues. This study is being done to learn more about the processes by which 18F-FAZA is absorbed, distributed, metabolized (built-up and broken down) and eliminated by the body.
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 |
|---|---|---|---|
| Hypoxic Tumours | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FAZA | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- First 5 consecutive 18F-FAZA avid subjects that undergo up to 5 PET scans, 13 blood and 2 urine samples over 4.5 hours
- interventionNames
- Other: 18F-FAZA
- label
- 2
- description
- Next 5 consecutive 18F-FAZA avid subjects that undergo up to 4 PET scans, 8 blood and 2 urine samples over 5.5 hours
- interventionNames
- Other: 18F-FAZA
Primary outcomes (1)
- measure
- To Collect imaging-based data for radiopharmacokinetic and radiodosimetric analyses.
- timeFrame
- 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male of Female \> or = to 18 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test required * Subjects with known primary or suspected metastatic SCC head and neck; NSCLC; SCLC; GBM; lymphoma, or NET with at least one lesion \> 1 cm in diameter * Able and willing to follow instructions and comply with the protocol * Provide written informed consent prior to participation in the study * Karnofsky Performance Scale Score of 70-100 Exclusion Criteria: * Previous treatment for their primary or metastatic SCC head and neck, NSCLC, SCLC, GBM, Lymphoma, or NET * Bilirubin \> or = to 200 umol/L * Creatinine \> or - to 150 umol/L * AST or ALT \> or = to 5 times the upper limits of normal * Serious medical conditions such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes * Nursing or pregnant females
References
Publications (0)
Data not yet available