TRAQinform Assessment of Immunotherapy Response

NCT05819255 | Completed FDA Device

• 2 other identifiers: AIQ 22-5832R44CA257253
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• To Investigate Intent to Change Treatment Decisions.

  Treatment response will be analyzed using TRAQinform Immuno Technology which is a software technology that identifies, matches, and quantifies metastatic cancer regions of interest. The clinical study will evaluate investigator questionaries to help understand the clinical impact of the addition of the TRAQinform Immuno analysis into the clinical work flow.

  12 weeks

Secondary Outcomes (1)

• Adverse Events and Treatment Efficacy Prediction

  4 weeks

Interventions

Non-Interventional OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with metastatic melanoma.

You may qualify if:

• Diagnosis of metastatic melanoma and is planned to start or has received one cycle of treatment with standard of care, dual-agent immunotherapy.
• Previous adjuvant anti-PD-I monotherapy is allowed. Patients must be greater than 6 months from the last treatment.
• Previous adjuvant BRAF/MEK therapy is allowed.
• Ability to tolerate 3 FDG PET/CT procedures. One at baseline, prior to the start of the combination immuno therapy, after 3 - 4 weeks of the combination immunotherapy treatment, and at 12 weeks of the combination treatment.
• Estimated life expectancy of greater than 12 months at screening.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at screening.
• Deemed suitable for starting standard of care combination immunotherapy for metastatic melanoma.
• Willing and able to provide informed consent for FDG PET/CT imaging.

You may not qualify if:

• Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial; places the patient at undue risk; or complicates the interpretation of the data, in the opinion of the investigator.
• A second malignancy
• Pregnancy or women who are breast feeding

Sponsors & Collaborators

• AIQ Solutions: lead
• National Cancer Institute (NCI): collaborator
• Massachusetts General Hospital: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: June 23, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

US (2)