[18F]-AraG PET Imaging in LA HNSCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-10-31

Brief Summary

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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.

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Detailed Description

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Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer globally. Definitive chemoradiotherapy (CRT) remains the standard of care (SOC) treatment for LA-HNSCC, yet some patients are unsuccessfully treated. The purpose of this study is to explore the feasibility and possible function of \[18F\]-AraG PET/CT (a diagnostic procedure that uses a radioactive tracer \[A method that uses radioactive substances to make pictures of areas inside the body\] to image tumors and assess response to treatment) scans performed before and during treatment to monitor response in patients undergoing chemoradiotherapy.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[18F]-AraG PET/CT scan

\[18F\]-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.

Group Type EXPERIMENTAL

[18F]-AraG radiotracer

Intervention Type DRUG

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

Chemotherapy

Intervention Type DRUG

Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.

Radiotherapy

Intervention Type DEVICE

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

Interventions

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[18F]-AraG radiotracer

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

Intervention Type DRUG

Chemotherapy

Concurrent chemoradiotherapy (CRT) with weekly doses of cisplatin.

Intervention Type DRUG

Radiotherapy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients ≥18 years of age.
2. Ability to provide written informed consent and HIPAA authorization.
3. 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).
4. Tumor stage III and IV (AJCC 8th edition).
5. Unresectable cases.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
7. Willing and able to maintain the imaging protocol.
8. Patients planning to receive pre-CRT and post-CRT FDG PET/CT scans as part of the standard clinical practice.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No