[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.

NCT05157659 | Active Not Recruiting

• 2 other identifiers: NL77310.029.212021-001489-40
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

\[18F\]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the ATTAIN trial is to investigate the pharmacokinetic characteristics of this novel tracer by performing a full kinetic modelling, assess test-retest (TRT) variability and to correlate the tumor tracer uptake with the pathological assessment.

Conditions

Non-Small Cell Lung Cancer

Keywords

Positron Emission Tomography; [18F]F-AraG; T-Lymphocytes; Kinetic Modelling; Reproducibility of Results

Outcome Measures

Primary Outcomes (2)

• Full kinetic modelling

  To perform full kinetic modeling of \[18F\]F-AraG for the uptake in tumor lesions and healthy organs (e.g. spleen) by exploring different kinetic models and outcome measures as well as its test-retest (TRT) variability to guide the selection of an optimal PET pharmacokinetic model.

  six months

• Correlation with number of CD8 T-cell

  To correlate the relationship between the tumor uptake of \[18F\]F-AraG and the number of CD8 T-cells amongst others as measured by Immunohistochemistry (IHC) and gene expression.

  six months

Secondary Outcomes (1)

• Correlation with [18F]-FDG PET uptake

  six months

Other Outcomes (1)

• Correlation with immune profile of PBMCs

  one year

Study Arms (1)

[18F]F-AraG PET procedures

EXPERIMENTAL

Within one week prior to resection two \[18F\]F-AraG PET-scans will be performed.

Diagnostic Test: [18F]F-AraG PET-scan

Interventions

[18F]F-AraG PET-scan DIAGNOSTIC_TEST

\[18F\]F-AraG PET scans are performed to assess the accumulation of activated T-cells in the tumour and healthy tissue.

[18F]F-AraG PET procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed NSCLC, a histological biopsy is mandatory.
• Patients that are resectable upfront as per multidisciplinary tumor board evaluation.
• Be willing and able to provide written informed consent for the trial.
• Be above 18 years of age on day of signing informed consent.
• Have a performance status of 0-1 on the ECOG Performance Scale at screening.

You may not qualify if:

• Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of screening. 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 \[18F\]F-AraG PET scan.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VU University Medical Center

Amsterdam, Nederland, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• I. Bahce, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. I. Bahce

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 15, 2021
• Study Start: December 1, 2021
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

NL (1)