Using a new imaging agent to detect head and neck cancers

Safety, Biodistribution and Radiation Dosimetry of [18F]PARPi

This study is testing a new imaging agent to see if it can help find head and neck cancers more clearly than current methods for patients getting treatment or surgery.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT03631017 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of a novel imaging agent called PARPi-FL for detecting head and neck cancers through PET/CT scans. Participants will undergo imaging to assess the presence of squamous cell carcinoma in the oral cavity, oropharynx, or nasopharynx. The study will involve two parts: one for patients scheduled for treatment and another for those undergoing surgery. The goal is to determine if this new imaging technique can provide clearer insights compared to traditional imaging methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven squamous cell carcinoma of the head and neck who are scheduled for treatment or surgery.

Not a fit: Patients with other types of head and neck cancers or those not scheduled for treatment at the participating institution may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved detection and treatment planning for patients with head and neck cancer.

How similar studies have performed: Other studies have shown promise in using novel imaging agents for cancer detection, but this specific approach is relatively novel.

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

Where this trial is running

New York, New York

• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)

Study contacts

• Principal investigator: Heiko Schöder, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Heiko Schöder, MD

Conditions: Head and Neck Cancer, Radiation Dosimetry of [18F]PARPi, PET/CT scans