Comprehensive Assessment of Cancer Theranostic Response
NCT ID: NCT06815354
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
32 participants
INTERVENTIONAL
2024-12-02
2026-05-29
Brief Summary
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Detailed Description
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The exploratory objective is to investigate if treatment efficacy and treatment-related toxicity can be detected by TRAQinform Theranostics in week 12 of 177Lu-PSMA (Pluvicto) treatment.
This clinical study will enroll 32 metastatic prostate cancer patients, planned to start treatment with 177Lu-PSMA (Pluvicto). Enrolled subjects will receive a 68Ga-PSMA or 18F-DCFPyL PET/CT and a diagnostic CT at baseline (SOC) and again at week 12 of the 177Lu-PSMA treatment. Week 12 PET/CT is for research purposes only and the 68PSMA or 18F-DCFPyL imaging agent may be considered investigational.
Following each imaging timepoint, scans will be transmitted to AIQ for analysis. At baseline and again at week 12, the investigator team, using the PET/CT and other relevant clinical data, will make a treatment decision without TRAQinform Theranostics and complete a questionnaire .
The TRAQinform Theranostics report will then be sent to the investigator team after the patient's treatment decision is made and the team again, will then provide answers to the questionnaire assessing how TRAQinform Theranostics would have impacted treatment decisions.
To address the status quo bias of each local investigator team, a blinded clinical evaluation of the week 12 questionnaire and any other anonymized clinical data necessary to make a treatment decision (prior taxane treatments, relevant labs, physical examination, treatment toxicities, and recent medical history) will be shared with each site. The investigator teams at each site will independently answer the week 12 questionnaire considering all information but without knowledge of the treatment decision made by the investigator teams at the other site.
It is important to note that the objective of this clinical study is to evaluate only the "intent" to change treatment. The investigator teams agree that patient treatment management decisions will not be affected by the additional information from TRAQinform Theranostics, and no clinical intervention will be implemented.
Conditions
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Study Design
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NA
SINGLE_GROUP
After each follow-up PET/CT, the local team will make a clinical decision about the care of the patient, using the PET/CT images and other relevant clinical data, but without information provided by TRAQinform Theranostics, and answer a investigator questonnaire. The design is modeled after intent-to-change studies con-ducted by the National Oncology PET Registry (NOPR).
OTHER
NONE
Study Groups
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Metastatic Prostate Cancer
32 patients with metastatic prostate cancer planned to start treatment with 177Lu-PSMA (Pluvicto) will be enrolled.
TRAQinform Theranostics
This prospective, multi-center, non-interventional clinical study will evaluate actionable outputs from TRAQinform Theranostics, a software only medical device that identifies, quantifies, tracks, and compares lesions between different imaging modalities and multiple imaging timepoints.
Interventions
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TRAQinform Theranostics
This prospective, multi-center, non-interventional clinical study will evaluate actionable outputs from TRAQinform Theranostics, a software only medical device that identifies, quantifies, tracks, and compares lesions between different imaging modalities and multiple imaging timepoints.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of metastatic prostate cancer.
* Planned to start 177Lu-PSMA (Pluvicto).
* Ability to tolerate two 68Ga-PSMA or 18F-DCFPyL PET/CT imaging procedures. One at baseline and at 12 weeks of 177Lu-PSMA (Pluvicto) treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at screening.
Exclusion Criteria
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Weill Medical College of Cornell University
OTHER
M.D. Anderson Cancer Center
OTHER
AIQ Solutions
INDUSTRY
Responsible Party
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Locations
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Weill Medical College of Cornell
New York, New York, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AIQ 24-3216
Identifier Type: -
Identifier Source: org_study_id
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