Back to results[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer. (ATTAIN)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
[18F]F-AraG PET-scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Small Cell Lung Cancer focused on measuring Positron Emission Tomography, [18F]F-AraG, T-Lymphocytes, Kinetic Modelling, Reproducibility of Results
Eligibility Criteria
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.
Sites / Locations
- Amsterdam UMC, location VU University Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]F-AraG PET procedures
Arm Description
Within one week prior to resection two [18F]F-AraG PET-scans will be performed.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Correlation with [18F]-FDG PET uptake
To correlate the [18F]-FDG PET uptake with uptake derived from [18F]F-AraG PET
Full Information
NCT ID
NCT05157659
First Posted
December 1, 2021
Last Updated
April 25, 2023
Sponsor
Amsterdam UMC, location VUmc
1. Study Identification
Unique Protocol Identification Number
NCT05157659
Brief Title
[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Amsterdam UMC, location VUmc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Positron Emission Tomography, [18F]F-AraG, T-Lymphocytes, Kinetic Modelling, Reproducibility of Results
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[18F]F-AraG PET procedures
Arm Type
Experimental
Arm Description
Within one week prior to resection two [18F]F-AraG PET-scans will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
[18F]F-AraG PET-scan
Intervention Description
[18F]F-AraG PET scans are performed to assess the accumulation of activated T-cells in the tumour and healthy tissue.
Primary Outcome Measure Information:
Title
Full kinetic modelling
Description
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.
Time Frame
six months
Title
Correlation with number of CD8 T-cell
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
Correlation with [18F]-FDG PET uptake
Description
To correlate the [18F]-FDG PET uptake with uptake derived from [18F]F-AraG PET
Time Frame
six months
Other Pre-specified Outcome Measures:
Title
Correlation with immune profile of PBMCs
Description
To explore the [18F]F-AraG PET uptake in tumor, lymph nodes and spleen with the immune profile of peripheral blood mononuclear cells (PBMC).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
I. Bahce, MD, PhD
Phone
+31204444782
Email
long@vumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I. Bahce, MD, PhD
Organizational Affiliation
Amsterdam UMC, location VUmc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amsterdam UMC, location VU University Medical Center
City
Amsterdam
State/Province
Nederland
ZIP/Postal Code
1081HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I Bahce, MD, PhD
Phone
0204444782
Email
i.bahce@amsterdamumc.nl
Email
long@vumc.nl
12. IPD Sharing Statement
Learn more about this trial
[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.
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