Clinical trial · Interventional
Imaging With a PET Agent for Detection of Cancers of the Head and Neck
Safety, Biodistribution and Radiation Dosimetry of [18F]PARPi
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
The purpose of this study is to test the safety of a study drug called PARPi-FL. This drug has been tested in animals but not yet in people. The purpose of this study is to test if a PARPi-FL scan can be used to take pictures of head and neck cancer. The usual approach to imaging this cancer includes several different imaging scans, including x-rays, CT (computed tomography), MRI (magnetic resonance imaging), and PET (positron emission tomography). These tests take pictures of the cancer.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]- PARPi | Drug | — | UNRESOLVED |
| PET/CT Scans | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase I: [18 F]-PARPi and PET/CT Scans
- description
- The intervention of this study is the injection of a microdose (\< 10 0 ug) of \[18 F\]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
- interventionNames
- Drug: [18F]- PARPi
- Diagnostic Test: PET/CT Scans
- type
- EXPERIMENTAL
- label
- Phase II: [18 F]-PARPi and PET/CT Scans
- description
- The intervention of this study is the injection of a microdose (\< 10 0 ug) of \[18 F\]- PARPi followed by 3 PET/CT studies to determine the biodistribution of this imaging agent in normal organs as well as the kinetics of uptake in squamous cell carcinomas of the head and neck.
- interventionNames
- Drug: [18F]- PARPi
- Diagnostic Test: PET/CT Scans
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Part 1: * Age ≥18 years * ECOG performance status 0 or 1 * Biopsy (histologically or cytologically) proven Squamos Cell Carcinoma * Oral cavity, oropharynx, or nasopharynx primary site * At least one tumor lesion on standard of care imaging with a minimum diameter of at least 1.5 cm * Scheduled to undergo treatment at MSKCC * Willingness to sign informed consent Part 2 * Age ≥18 years * ECOG performance status 0 or 1 * Biopsy (histologically or cytologically) proven Squamous Cell Carcinoma * Oral cavity,oropharynx, or nasopharynx primary site * Scheduled to undergo surgery (neck dissection and/ or neck dissection + surgical removal of the primary) at MSK * Willingness to sign informed consent * Should have had a standard-of-care \[18F\]-FDG PET/CT scan before surgery (to minimize the possibility of new alterations developing between the two scans both scans should be acquired within a maximum time difference of one month). Exclusion Criteria: * Significantly impaired organ function that may interfere with the excretion and metabolism of the imaging agent. Specifically, patients will be excluded if they meet the following criteria: * Hematologic o Platelets \<75K/mcL * Hepatic * Bilirubin \>2.0 x ULN (institutional upper limits of normal) * AST/ALT \>2.5 x ULN * Renal o Creatinine \> 2.0 x ULN * Claustrophobia interfering with PET/CT imaging * Known allergy to PEG300 * Pregnancy or breastfeeding
References
Publications (0)
Data not yet available