NCT05819255

TRAQinform Assessment of Immunotherapy Response

Comprehensive Assessment of Cancer Immunotherapy Response; Investigating the Intent to Change Treatment Decisions Based Upon TRAQinform Immuno Technology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: AIQ Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The intent of this study is to evaluate the actionable information output from the TRAQinform Immuno technology in a prospective, non-interventional clinical study. Subjects with metastatic melanoma treated with standard of care (SOC) dual-agent immunotherapy will be enrolled. Subjects will receive SOC immunotherapy monitored for treatment response with FDG PET/CT's at baseline (SOC), after 3-4 weeks of treatment (non-SOC) and 12 at weeks of treatment (SOC).

Detailed description

This prospective, non-interventional clinical study will enroll patients with metastatic melanoma, who have been selected by their oncologist to receive standard of care (SOC) dual-agent immunotherapy and monitored for treatment response using SOC FDG PET/CTs. The primary objective of this clinical study is to investigate intent to change treatment decisions after the addition of treatment response information from the TRAQinform Immuno technology. For each subject, FDG PET/CT #1, #2 and #3 will be transmitted to AIQ Solutions (Madison, WI) for treatment response analysis using TRAQinform Immuno, a software technology that identifies, matches and quantifies metastatic cancer regions of interest. A TRAQinform Immuno report will be returned to the oncology/nuclear medicine paired investigator teams, after the first clinical decision point following FDG PET/CT #1 and #2 and again after the second clinical decision point following FDG PET/CT #3. The investigator team at each site will complete an "intent to change" questionnaire for each subject at Data Collection Point #1 and at Data Collection Point #2. The clinical study will evaluate the Data Collection Point questionnaires to help understand the clinical impact of the addition of TRAQinform Immuno analysis into the clinical workflow. To address the status quo bias of the investigator teams, the TRAQinform Immuno reports for subjects enrolled at each site, including the additional limited data that is necessary to make a treatment decision, will be shared between teams. The first investigator team, without knowledge of the treatment decision made by the second investigator team, will independently answer the Data Collection Point #3 questionnaire and vice versa. An exploratory objective of this clinical trial is to investigate if treatment effectiveness and adverse events could be detected on FDG PET/CT images at 3-4 weeks of the combination immunotherapy.

Conditions

• Melanoma

Interventions

Type	Name	Description
OTHER	Non-Interventional	This prospective, non-interventional clinical study will enroll patients with metastatic melanoma, who have been selected by their oncologist to receive standard of care dual-agent immunotherapy and monitored for treatment response using SOC FDG PET/CTs. The primary objective of this clinical study is to investigate intent to change treatment decisions after the addition of treatment response information from the TRAQinform Immuno technology.

Timeline

• Start date: 2023-06-23
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2023-04-19
• Last updated: 2025-08-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study