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

Non-Small Cell Lung Cancer Clinical Trial

— ATTAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157659
• Other study ID #: NL77310.029.21
• Secondary ID: 2021-001489-40
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Amsterdam UMC, location VUmc
• Contact: I. Bahce, MD, PhD
• Phone: +31204444782
• Email: long[@]vumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2024
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Diagnostic Test:
• [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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VU University Medical Center	Amsterdam	Nederland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation with immune profile of PBMCs	To explore the [18F]F-AraG PET uptake in tumor, lymph nodes and spleen with the immune profile of peripheral blood mononuclear cells (PBMC).	one year
Primary	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
Primary	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	Correlation with [18F]-FDG PET uptake	To correlate the [18F]-FDG PET uptake with uptake derived from [18F]F-AraG PET	six months