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New PET tracer aims to light up head and neck tumors

NCT ID NCT03631017

Diagnosis Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This early-phase trial is testing the safety of a new imaging drug called [18F]PARPi in 12 people with head and neck cancer. The drug is designed to make cancer cells show up more clearly on PET/CT scans. The goal is to see if this approach can provide better pictures of tumors than current standard imaging methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
[18F]PARPi (a radioactive imaging agent)
What this could lead to
If successful, this could lead to a new, more precise way to image head and neck cancers using a PET scan.
What could go wrong
This is a very early, small study (12 people) focused on safety and imaging quality, not treatment. The imaging agent may not work as hoped or could cause unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

12 people

The number who actually took part.

Started

Aug 2018

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.