A clinical imaging Study of the changes in [18F]F-AraG uptake following radiotherapy in Non-small cell lung cancer.

Recruiting

• Conditions: breast cancer; esophageal cancer; lung cancer; lung carcinoma; melanoma; 10038666; 10029107

• Registration Number: NL-OMON52284
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

• Histologically confirmed NSCLC, melanoma, esophageal, or breast cancer
• Ongoing immunotherapy using an anti-PD-(L)1 agent
• Planned to be treated with high dose (24Gy) radiotherapy per clinical
indication
• Be willing and able to provide written informed consent for the trial.
• Have a performance status of 0-2 on the ECOG Performance Scale
• Be above 18 years of age on day of signing informed consent.

Exclusion Criteria

• Subjects with a condition requiring systemic treatment with either
corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive
medications within 14 days of day 0. Inhaled or topical steroids, and adrenal
replacement steroid >10 mg daily prednisone equivalent, are permitted in the
absence of active autoimmune disease.
• Psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
• Patient is pregnant or breastfeeding, or expecting to conceive within the
projected duration of the trial, starting with the screening visit through 12
weeks after the last administration of [18F]F-AraG.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1.To assess the relative change in uptake of [18F]F-AraG in tumor lesions on<br /><br>anti-PD-1 treatment<br /><br>a. To define tracer uptake in all tumor lesions and lymphoid organs (lymph<br /><br>nodes, spleen) per [18F]F-AraG PET scan<br /><br>b. To assess the changes in uptake between baseline and after 1 and 3 weeks<br /><br>on-treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>N/A</p><br>