This study has been transitioned to CTIS with ID 2024-517960-45-00 check the CTIS register for the current data. • To assess the relative change in uptake of [18F]F-AraG in tumor lesions upon anti-PD-1 treatment• To assess the relationships between…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1.To assess the relative change in uptake of [18F]F-AraG in tumor lesions on
anti-PD-1 treatment
a. To define tracer uptake in all tumor lesions and lymphoid organs (lymph
nodes, spleen) per [18F]F-AraG PET scan
b. To assess the changes in uptake between baseline and after 1 and 3 weeks
on-treatment
Secondary outcome
N/A
Background summary
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 will greatly help in
identifying *hot* tumors, or parts of the tumor mass that have high
concentrations of tumor infiltrating T-cells. A promising tracer to image
activated T-cells is [18F]F-AraG. We hypothesized that baseline tumor
[18F]F-AraG uptake and increase of tumor [18F]F-AraG accumulation will give a
good indication of in-vivo changes in the TME upon radiotherapy. As [18F]F-AraG
will accumulate in activated T-cells, and the concentration of activated
T-cells will increase in the TME onradiotherapy, we expect that tumor
[18F]F-AraG uptake will increase on radiotherapy. Therefore, the aim of this
project is to investigate the changes in tumor uptake of [18F]F-AraG in cancer
patients
Study objective
This study has been transitioned to CTIS with ID 2024-517960-45-00 check the CTIS register for the current data.
• To assess the relative change in uptake of [18F]F-AraG in tumor lesions upon
anti-PD-1 treatment
• To assess the relationships between baseline tumor [18F]F-AraG uptake, change
of tumor [18F]F-AraG uptake and tumor response to anti-PD-1 therapy
Study design
single center, single arm, open-label, non-controlled, non-randomised imaging
trial, N=12
Intervention
all patients will undergo 3 [18F]F-AraG PET scanning procedures according to
the institutional protocols
Study burden and risks
All patients will undergo 3 [18F]F-AraG scanning procedures. Prior to the
injection of tracer, venous blood will be drawn for immunological assessment of
PBMC*s. Per scanning procedure, patients will be lying for approximately 90
minutes on the scanner and patients will receive a radiation burden of 5.7 mSv
per scanning procedure. In all patients, a venous cannula will be inserted in
an arm vein and to drawn blood (7cc), manually at 2 time point. Patients will
derive no direct benefit from participating in this trial. The insights
obtained in the translational part of this study can be of high interest for
future cohorts of cancer patients.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
• Histologically confirmed NSCLC, melanoma, esophageal, or breast cancer
• Ongoing immunotherapy using an anti-PD-(L)1 agent
• Planned to be treated with high dose (24Gy) radiotherapy per clinical
indication
• Be willing and able to provide written informed consent for the trial.
• Have a performance status of 0-2 on the ECOG Performance Scale
• Be above 18 years of age on day of signing informed consent.
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 day 0. 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 administration of [18F]F-AraG.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-517960-45-00 |
| EudraCT | EUCTR2021-003986-36-NL |
| CCMO | NL78588.029.21 |