18F F-AraG-PET Imaging to Evaluate Immunological Response CKI Therapy in Solid Tumors Imaging

Solid Tumor Clinical Trial

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 Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05219981
• Other study ID #: IRB-58073
• Secondary ID: VAR0178
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2022
• Est. completion date: June 2026

Study information

• Verified date: February 2022
• Source: Stanford University
• Contact: Maria Isabel Galvez Leonio, MD
• Phone: 6507230371
• Email: ileonio[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is A pilot study of using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor

Description:

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. Correlation of pre and post treatment intratumoral immune filtration by means of PET imaging will guide the development of future clinical trials investigating the role of [18F]F AraG in the monitoring of anti tumor immune responses.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with solid malignancy with planned CkIT treatment as part of their anticancer therapy
• Patient must be = 18 years old
• Documented written informed consent
• A review of prior imaging studies of the patient (CT, MR, or other applicable imaging modality obtained within 28 days prior to CkIT treatment. The patient must have two (2) eligible lesions for AraG PET imaging and biopsy: each lesion must be > 1cm diameter in short axis, with IR investigator's approval for biopsy.

Exclusion Criteria:

• Patient is pregnant or breast feeding

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• Fluorine F 18 Ara-G
patients will undergo 2 research PET/CT imaging with [18F]F AraG

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies		24 months
Secondary	Correlate changes in [18F]F AraG signal on PET imaging to composite endpoints of clinical benefits using iRECIST criteria	Clinical benefits is defined as a patient who experience CR+PR+SD for more than 4 months	24 months
Secondary	Correlate changes in [18F]F AraG uptake on PET scan to occurrence of adverse events	Demonstrate correlation between the change in [18F]F AraG signal in lung and GI tract wall with the occurrence of immune related adverse events.	24 months