ACTIVE_NOT_RECRUITING

A Dye for the Detection of Cancer of the Tongue and Mouth

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Conditions

Oral Squamous Cell Carcinoma (OSCC)TongueMouthFluorescent PARP1 Binding Imaging AgentPARPi-FL15-336

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas

Quick Facts

Study Start:2017-03-15
Study Completion:2026-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03085147

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is ≥ 18 years old
  2. * Histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (OSCC)
  3. * Scheduled to undergo surgery at MSK
  4. * Any tumor stage, any N, M0
  5. * ECOG performance status 0 or 1
  1. * Any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks
  2. * Prior or ongoing treatment with a PARP1 inhibitor
  3. * Known hypersensitivity to Olaparib
  4. * Known hypersensitivity to PEG Eligibility criteria will be assessed by an experienced oral surgeon, typically the Co-PI of the study.

Contacts and Locations

Principal Investigator

Heiko Schoder, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk-Commack (Consent only)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Consent only)
Rockville Centre, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Heiko Schoder, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-15
Study Completion Date2026-07

Study Record Updates

Study Start Date2017-03-15
Study Completion Date2026-07

Terms related to this study

Keywords Provided by Researchers

  • Tongue
  • Mouth
  • Fluorescent PARP1 Binding Imaging Agent
  • PARPi-FL
  • 15-336

Additional Relevant MeSH Terms

  • Oral Squamous Cell Carcinoma (OSCC)