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PET Imaging with PARPi for Head and Neck Cancer
Phase 1 & 2
Recruiting
Led By Heiko Schöder, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part 1: Age ≥18 years
Part 2: Biopsy proven Squamous Cell Carcinoma at oral cavity, oropharynx, or nasopharynx primary site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if PARPi-FL is safe for humans and if it can be used to take pictures of head and neck cancer like other imaging tests.
Who is the study for?
This trial is for adults over 18 with Squamous Cell Carcinoma in the oral cavity, oropharynx, or nasopharynx. They should have at least one tumor visible on standard scans that's bigger than 1.5 cm and be scheduled for treatment at MSKCC. Participants need to be fairly active (ECOG status 0-1) and willing to consent.Check my eligibility
What is being tested?
The study is testing a new imaging drug called PARPi-FL in people for the first time, aiming to see if it can effectively image head and neck cancer using PET/CT scans compared to usual methods like x-rays, CT, MRI, and PET alone.See study design
What are the potential side effects?
Since PARPi-FL is new and hasn't been tested in humans before this trial, potential side effects are unknown but will be closely monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is a type of Squamous Cell Carcinoma located in my mouth, throat, or nasal area.
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I can carry out all my daily activities without help.
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My cancer is confirmed as Squamous Cell Carcinoma in my mouth or throat.
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I am 18 years old or older.
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I am scheduled for neck surgery at MSK.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
severity of adverse events
Trial Design
2Treatment groups
Experimental Treatment
Group I: Phase II: [18 F]-PARPi and PET/CT ScansExperimental Treatment2 Interventions
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.
Group II: Phase I: [18 F]-PARPi and PET/CT ScansExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,930 Previous Clinical Trials
597,351 Total Patients Enrolled
Heiko Schöder, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
1,263 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this clinical trial?
"Currently, this medical trial specified on clinicaltrials.gov has reached its recruitment limits and is no longer searching for candidates. This study was initially made available on August 10th 2018 and last edited September 14th 2022; however, 480 alternative studies are actively recruiting patients at present."
Answered by AI
What are the potential risks to individuals undergoing PET/CT scans?
"PET/CT Scans have only limited supportive evidence in terms of efficacy and safety, so they received a score of 1."
Answered by AI
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