NCT07168785

Brief Summary

This study will use \[18F\]-AraG PET/CT scans to monitor patients who have been diagnosed with locally advanced Head and Neck Squamous Cell carcinoma (LA-HNSCC), and are planning to undergo standard of care chemoradiotherapy for treatment.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for early_phase_1

Timeline
17mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Oct 2025Oct 2027

First Submitted

Initial submission to the registry

August 27, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

August 27, 2025

Last Update Submit

September 4, 2025

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

AraG PET/CTChemoradiotherapy[18F]-AraG PET/CT

Outcome Measures

Primary Outcomes (3)

  • [18F]-AraG PET/CT uptake and infiltrating cytotoxic T-cell expression.

    Examining the distribution of \[18F\]-AraG PET SUV metrics and counts of CD3+/CD8+/PD1- and CD3+/CD8+/PD1+ T-cells

    Week 1 and Week 16

  • Pre-treatment [18F]-AraG PET/CT uptake and clinical response.

    Correlation of pre-treatment \[18F\]-AraG PET/CT metrics (such as SUVmax, mean and uptake volume) and clinical response.

    Pre-treatment

  • Changes between pre-treatment and mid-treatment [18F]-AraG PET/CT uptake and clinical response

    Correlation between percentage changes in PET uptake values (max, mean, and peak) at pre- and mid-CRT and treatment response categories.

    Pre-treatment and Week 16

Secondary Outcomes (3)

  • Individual cytotoxic T-cell activities (CD3+, CD8+, PD1-, and PD1+) and pre-treatment [18F]-AraG PET/CT uptake

    Pre-Treatment

  • Tumor extent and standard uptake values between FDG PET and [18F]-AraG PET/CT imaging

    treatment planning through post treatment ( up to 6 months)

  • [18F]-AraG PET/CT uptake over time and progressive-free survival

    up to 6 months

Study Arms (1)

[18F]-AraG PET/CT scan

EXPERIMENTAL

\[18F\]-AraG PET/CT scans to be performed according to the institution's standard of operation, which occurs on the first and sixteenth day of treatment.

Drug: [18F]-AraG radiotracerDrug: ChemotherapyDevice: Radiotherapy

Interventions

[18F]-AraG radiotracerDRUG

\[18F\]-AraG radiotracer, which occurs on the first and sixteenth day of treatment.

[18F]-AraG PET/CT scan
ChemotherapyDRUG

Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.

[18F]-AraG PET/CT scan
RadiotherapyDEVICE

Concurrent chemoradiotherapy (CRT) of 70Gy of radiation dose in 33 fractions.

[18F]-AraG PET/CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years of age.
  • Ability to provide written informed consent and HIPAA authorization.
  • LA-HNSCC in the larynx, hypopharynx, or human papillomavirus (HPV) negative oropharynx and is planning to receive definitive CRT as the SOC treatment, which includes a total of 70 Gy of radiation dose in 33 fractions, delivered over 5 days a week for 7 weeks, as well as planned weekly cycles of cisplatin (CDDP).
  • Tumor stage III and IV (AJCC 8th edition).
  • Unresectable cases.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Willing and able to maintain the imaging protocol.
  • Patients planning to receive pre-CRT and post-CRT FDG PET/CT scans as part of the standard clinical practice.

You may not qualify if:

  • Diagnosis of immunodeficiency or receiving systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the PET/CT scan.
  • Pregnant or breastfeeding.
  • Patients that will receive definitive induction chemotherapy or surgery.
  • Patients who are unable to complete the radiation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Drug TherapyRadiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mark Langer

    Indiana University Simon Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn I Lauer

CONTACT

(317) 962-8969kilauer@iu.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Radiation Oncology

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 11, 2025

Study Start

October 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations

US(1)