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

  • STATUS
    Recruiting
  • End date
    Jun 24, 2024
  • participants needed
    10
  • sponsor
    VU University Medical Center
Updated on 24 March 2022
lung carcinoma

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.

Description

The efficacy of immunotherapy and patient selection for combinatorial immunotherapy strategies would greatly improve if the tumor microenvironment (TME) could be characterized more accurately. Positron emission tomography (PET) using tracers that target immune cell subsets may provide a non-invasive means to immune profile the TME. Imaging T-cells can help in identifying 'hot' tumors, or parts of the tumor mass that have high concentrations of tumor infiltrating T-cells and also provide information on its activation.

A promising tracer to image activated T-cells is [18F]F-AraG. Based on the hypothesis that [18F]F-AraG will accumulate in activated T-cells, it is expected that [18F]F-AraG and PET will enable to (reproducibly) identify tumors and tumor areas with high concentrations of tumor infiltrating activated T-cells on pathological assessment. In the ATTAIN trial this [18F]F-AraG uptake in tumor lesions and healthy organs is explored by full kinetic modelling.

Details
Condition Non-Small Cell Lung Cancer
Treatment [18F]F-AraG PET-scan
Clinical Study IdentifierNCT05157659
SponsorVU University Medical Center
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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 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
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