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Multimodal Machine Learning Characterization of Solid Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Multimodal Machine Learning Characterization of Solid Tumors

Multimodal PET/MRI Machine Learning Approaches for Characterization of Solid Tumors

NCT04687969•Ciprian Catana, MD, PhD

Summary

This research study wants to develop advanced imaging methods to more accurately characterize prostate cancer or solid tumor aggressiveness. This observational study involves \[18F\]DCFPyL positron emission tomography and magnetic resonance imaging (PET/MRI)

Detailed Description

This is an observational imaging study to evaluate the value of multimodal \[18F\]DCFPyL positron emission tomography and magnetic resonance imaging (PET/MRI) for solid tumor characterization and disease staging. This research study involves: * Screening visit, and 1-3 study Multimodal \[18F\]DCFPyL PET/MRI visits * Two cohorts of participants will be enrolled in this study: primary prostate cancer patients and patients with known or suspected solid tumors (hepatocellular carcinoma, glioma, clear cell renal carcinoma) * It is expected that about 135 people will take part in this research study * The PET dye used in this study is called \[18F\]DCFPyL. \[18F\]DCFPyL is approved by the U.S. Food and Drug administration (FDA). * The PET/MRI scanner was approved by the U.S. FDA.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must meet the following criteria on screening examination to be eligible to participate in the study:
•* Must have primary prostate cancer (e.g. adenocarcinoma of prostate) and deemed a candidate for radical prostatectomy as part of standard clinical care for Cohort A.
•* Must have evidence or be suspected of having HCC, Glioma and RCC for enrollment in Cohort B.
•* Age ≥18 years.
•\--- Because no dosing or adverse event data are currently available on the use of \[18F\]DCFPyL in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
•* Participants must have adequate kidney function for gadolinium-based contrast administration as assessed by:
•* estimated or measured glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m2 for repeated administrations.
•* a single dose will be administered to subjects with a GFR between 30-60 mL/min/1.73 m2. Investigators will not repeat the gadolinium-based contrast agent administration until the renal function improves and the GFR is higher than 60 cc/min/1.73 m2. These subjects will not undergo examinations on consecutive days even if the renal function improves.
•Patient must be able to undergo MRI and PET scans.
•Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

•History of allergic reactions attributed to compounds of similar chemical or biologic composition to the PET radiotracer, \[18F\]DCFPyL.
•Participants determined by the investigator(s) to be clinically unsuitable for the study.
•Patients who are not suitable to undergo MRI or PET or use gadolinium contrast due to:
•* Presence of ferromagnetic implants or implanted medical devices in body (i.e. cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body. tattoos near the eye, or steel implants)
•* Claustrophobia
•* Research-related radiation exposure exceeding current Massachusetts General Hospital (MGH) Radiology Department guidelines (i.e. 50 millisievert in the prior 12 months)
•* Inability to lie comfortably on bed inside the PET/MRI scanner
•* Body weight of \> 300 lbs (weight limit of the MRI table)
•* Reduced renal function as determined by creatinine or GFR values defined above obtained within 30 days prior to registration
•* Pregnancy

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, United States

Key Dates

Start Date

October 23, 2022

Primary Completion Date

August 31, 2024

Completion Date

December 31, 2025

Last Updated

September 25, 2025

Enrollment

135

ESTIMATED participants

Conditions

Adenocarcinoma of ProstateRadical ProstatectomyHepatocellular Carcinoma (HCC)GliomaRenal Cell Carcinoma (RCC)Prostate Cancer

Interventions

[18F]DCFPyL

DRUG

PET/MRI scanner

RADIATION

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

NCT07291076

Hepatocellular Carcinoma (HCC)

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RECRUITINGPHASE3

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

NCT07427043

Opioid Consumption, PostoperativeMultimodal Analgesia+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Multimodal Machine Learning Characterization of Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)

Robotic Opioid-free Prostatectomy Enhanced Strategy (ROPES)

NIS on the Benefits of TIPS in Patients With HCC Receiving Atezo+Bev in 1st-Line Therapy

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

The Treatment of Liver Injury After Liver Resection With Polyene Phosphatidylcholine

A Two-Arm, Multicenter, Non-Randomized Controlled Study on the Efficacy of Yttrium-90 (Selective Internal Radiation Therapy) Therapy and Hepatic Arterial Infusion Chemotherapy (Hepatic Artery Infusion Chemotherapy) for Potentially Resectable Intermediate and Advanced Hepatocellular Carcinoma