NCT04687969

Multimodal Machine Learning Characterization of Solid Tumors

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 135 (estimated)
• Sponsor: Ciprian Catana, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of Prostate
• Radical Prostatectomy
• Hepatocellular Carcinoma (HCC)
• Glioma
• Renal Cell Carcinoma (RCC)
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	[18F]DCFPyL	will either be administered by intravenous injection by bolus by a qualified nuclear medicine technician at the Martinos Center, or will be administered as part of a clinical PET/CT examination
RADIATION	PET/MRI scanner	PET/MRI Scan with \[18F\]DCFPyL as directed by protocol

Timeline

• Start date: 2022-10-23
• Primary completion: 2024-08-31
• Completion: 2025-12-31
• First posted: 2020-12-29
• Last updated: 2025-09-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study