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Imaging With a PET Agent for Detection of Cancers of the Head and Neck

StatusActive, Not Recruiting
PhasePhase 1/2
Started2018-08-10
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-02
critical
Study Status v18
Primary completion pushed: 2026-08 → 2027-08
Completion pushed: 2026-08 → 2027-08
2025-09-02
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-08→2026-08
Completion date2025-08→2026-08
Enrollment targetestimated 27→confirmed 12
Study sitesdetails revised at 1 of 1 site
2025-01-10
minor
2 amendments v15-v16
2 re-verifications since 2024-01-09, no change to tracked fields
2023-09-11
minor
Study Status v14
Primary completion date2023-08→2025-08
Completion date2023-08→2025-08
2023-07-18
minor
Study Status, Study Design v13
Re-verified, no change to tracked fields
Show 12 earlier versions
2023-07-17
minor
Study Status, Study Design, Arms and Interventions, Eligibility v12
PhasePhase 1→Phase 1/2
Enrollment target12→27
Study arms1→2
Eligibility criteria+564 characters
Inclusion Criteria: Part 1: Age ≥18 years ECOG performance status 0 or 1 Biopsy (histolo [...] rgo 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 [...] Exclusion Criteria: Significantly impaired organ function th [...]
2023-03-23
notable
Active, Not Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v11
Trial statusActive, Not Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2022-09-14
minor
Study Status v10
Primary completion date2022-08→2023-08
Completion date2022-08→2023-08
2021-09-14
minor
Study Status v9
Primary completion date2021-08→2022-08
Completion date2021-08→2022-08
2020-09-14
minor
Study Status v8
Primary completion date2020-08→2021-08
Completion date2020-08→2021-08
2020-03-30
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2019-07-09
minor
2 amendments v5-v6
2 re-verifications since 2019-04-04, no change to tracked fields
2019-03-18
minor
Study Status, Eligibility v4
Eligibility criteria-45 characters
Inclusion Criteria: Age ≥18 years ECOG performance status 0 or 1 Biopsy (histologically or cytologically) proven oralSquamos Cell Carcinoma Oral cavity, oropharynx, or nasopharynx primary site At least on [...] d of care imaging with a minimum diameter of at least 1.5 cm with histologically or cytologically proven squamous cell carcinoma Scheduled to undergo treatment at MSKCC Willingness to sign [...]
2019-01-04
minor
Study Status v3
Re-verified, no change to tracked fields
2018-12-18
minor
Study Status, Eligibility v2
Eligibility criteria+14 characters
[...] Biopsy (histologically or cytologically) proven oral cavity, oropharynx, or oropharynxnasopharynx primary site At least one tumor lesion on standard of care [...]
2018-10-10
minor
Study Status, Eligibility, Contacts/Locations v1
Eligibility criteria+42 characters
Inclusion Criteria: Age ≥18 years ECOG performance status 0 or 1 OralBiopsy (histologically or cytologically) proven oral cavity or oropharynx primary site At least one tumor lesion [...] gically proven squamous cell carcinoma Scheduled to undergo surgicaltreatment tumorat resectionMSKCC Willingness to sign informed consent Exclusion Criteria: Si [...]
Study sitescontacts updated at 1 of 1 site
2018-08-14
minor
Original filing
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.
Trial Details
NCT Number NCT03631017
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Head and Neck Cancer
Enrollment 12 participants
Start Date 2018-08-10
Primary Completion 2027-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-08