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

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2025-06-30

Brief Summary

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\[18F\]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.

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Detailed Description

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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.

Conditions

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Non-Small Cell Lung Cancer

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]F-AraG PET procedures

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

Group Type EXPERIMENTAL

[18F]F-AraG PET-scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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[18F]F-AraG PET-scan

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
3. 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No