Clinical trial NCT04260256: A Study Using [18F]F AraG PET to Evaluate Response to Checkpoint Inhibitor Therapy(CkIT) in Patients With Solid Tumors
Official title: A Pilot Study of Using [18F]F AraG PET Imaging to Evaluate the Immunological Response to Checkpoint Inhibitor Therapy (CkIT) in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit
Lead sponsor: CellSight Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
name: Oregon Health and Science University
First posted: 2020-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, patients with advanced solid tumors will undergo \[18F\]F AraG PET/CT imaging to assess for changes in tracer uptake following treatment with CkIT.

Detailed description: Up to 40 patients will be recruited to participate in this study. Two (2) target lesions per patient will be selected for radiomics and biopsy. Both lesions will be assessed for \[18F\]F AraG uptake before and after CkIT. Only one lesion will be biopsied twice (once before and once after CkIT treatment close to the time of imaging), and the other lesion will not be manipulated and used as a control.

There will be a pre therapy scan \[18F\]F AraG which will be administered anytime within a 14 day period prior to the initial Day 1 CkIT administration. There will also be a post therapy scan which will be performed within 3 to 6 weeks after the initial CkIT dose. The timing of the second \[18F\]F AraG scans may be altered based on preliminary results from the initial patient scan results, and could be obtained during the first 2 weeks after initiation of therapy.

The investigators will compare the \[18F\]F AraG activity (based on development of tumoral volumes of interest (VOIs) pre and post CkIT in both lesions.

Eligibility criteria: Inclusion Criteria:

* Solid tumor with planned CkIT
* Must be \>18 years old
* Signed Informed Consent Form
* Patient must have two qualifying lesions

Exclusion Criteria:

* Patient is pregnant or breast feeding

Primary outcomes:
measure: Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies
timeFrame: 24 Months
Secondary outcomes:
measure: 1. Correlate change in [18F]F AraG uptake signal in tumor lesions with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) > 4 months) using iRECIST criteria
timeFrame: 24 Months
measure: 2. Correlate change in [18F]F AraG signal in lung and GI tract with the occurrence of Grade 3 or 4 immune related adverse events.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Stanford University
name: Carina Mari Aparici, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Erik Mittra, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Shivaani Kummar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: