Clinical Trial Finder
A Dye for the Detection of Cancer of the Tongue and Mouth
Study Purpose
The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.
Recruitment Criteria
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
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Inclusion Criteria:
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Trial Details
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Arms
Experimental: Fluorescent PARPi Binding Imaging Agent PARPi-FL
In the phase I of the study, increasing concentrations of PARPi-FL will be used in up to 12 patients with OSCC to determine concentration that results in the highest contrast between tumor and normal mucosa. Dose escalation will be performed in groups of three patients until image contrast decreases, side effects are noted or the concentration of PARPi-FL exceeds 1μM. Imaging will be performed in the Department of Surgery during a presurgical visit including clinical examination of the oral cavity. In the phase II part of the study the concentration of PARPi-FL determined in phase I will be used to image 18 patients with OSCC on the day of surgery. Imaging findings will be correlated with histopathologic findings in the surgically resected specimens.
Interventions
Drug: - Olaparib
For PARRi-FL, imaging patients will first gargle a solution of PARRi-FL for 1 min, then spit out this solution and gargle with a cleaning solution (the solvent used for PARRi-FL) for 1 min. Then fluorescence imaging of the oral cavity and pharynx will be performed with an endoscope. The intensity and extent of the fluorescence signal will be recorded by one of the investigators for the tumor and adjacent normal mucosa.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
Site Contact
Heiko Schoder, MD
[email protected]
212-639-2079
Status
Recruiting
Address
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
Site Contact
Heiko Schoder, MD
[email protected]
212-639-2079
Status
Recruiting
Address
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645
Site Contact
Heiko Schoder, MD
[email protected]
212-639-2079
Status
Recruiting
Address
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, New York, 11725
Site Contact
Heiko Schoder, MD
[email protected]
212-639-2079
Status
Recruiting
Address
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
Site Contact
Heiko Schoder, MD
[email protected]
212-639-2079
Status
Recruiting
Address
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Site Contact
Heiko Schoder, MD
[email protected]
212-639-2079
Status
Recruiting
Address
Memorial Sloan Kettering Nassau (Consent only)
Rockville Centre, New York, 11553
Site Contact
Heiko Schoder, MD
[email protected]
212-639-2079
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