NCT04260256

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2022

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

February 5, 2020

Last Update Submit

March 24, 2026

Conditions

Correlate Tracer Uptake to TCell Tumor Infiltration & CkIT Benefit

Outcome Measures

Primary Outcomes (1)

  • Correlate change in [18F]F AraG signal following CkIT therapy with change in level of T cell infiltration in tumor biopsies

    Pre and post CkIT biopsies of the same tumor lesion will be performed an analyze T-cell tumor infiltration, this will be correlated to \[18F\]F-AraG PET signal.

    24 Months

Secondary Outcomes (2)

  • 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

    24 Months

  • 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.

    24 Months

Interventions

[18F]F-AraGDRUG

\[18F\]F AraG injection and PET Scan Two tumor biopsies of single lesion

Also known as: VisAcT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patient is pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Study Officials

  • Carina Mari Aparici, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Erik Mittra, M.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Shivaani Kummar, M.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2020

First Posted

February 7, 2020

Study Start

March 1, 2022

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)