Clinical trial NCT03631017: Imaging With a PET Agent for Detection of Cancers of the Head and Neck
Official title: Safety, Biodistribution and Radiation Dosimetry of [18F]PARPi
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Keywords: Radiation Dosimetry of [18F]PARPi
PET/CT scans
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an open label, investigator initiated single arm, first in human study of a PARP1/2 imaging agent in patients with head and neck squamous cell carcinomas scheduled to undergo surgery.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

* 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:
* 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
* Claustrophobia interfering with PET/CT imaging

  * Known allergy to PEG300
  * Pregnancy or breastfeeding

Primary outcomes:
measure: severity of adverse events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Heiko Schöder, MD
role: PRINCIPAL_INVESTIGATOR
References: