NCT03631017Active, not recruitingPhase 1/2
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 · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 11 Aug 2018
- Start date
- 10 Aug 2018
- Primary completion date
- Aug 2027
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Head and neck cancer
- NCT number
- NCT03631017
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 12
- From 10 Aug 2018 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Claustrophobia interfering with PET/CT imaging
- Known allergy to PEG300
- Pregnancy or breastfeeding
Lab values
- 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
Other
- 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:
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.