Multimodal Machine Learning Characterization of Solid Tumors

NCT ID: NCT04687969

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-23
• Study Completion Date: 2025-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COHORT A: PROSTATE CANCER PATIENTS

Primary prostate cancer patients scheduled to undergo radical prostatectomy.

• Twenty five (25) prostate cancer patients will undergo two [18F]DCFPyL PET/MRI scans and
• Sixty (60) additional prostate cancer patients will undergo one [18F]DCFPyL PET/MRI scan.

[18F]DCFPyL

Intervention Type: DRUG

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

PET/MRI scanner

Intervention Type: RADIATION

PET/MRI Scan with \[18F\]DCFPyL as directed by protocol

COHORT B: SOLID TUMOR PATIENTS

Patients with known or suspected solid tumors (hepatocellular carcinoma, glioma, clear cell renal carcinoma).

Up to fifty (50) patients will undergo up to three [18F]DCFPyL PET/MRI scans

[18F]DCFPyL

Intervention Type: DRUG

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

PET/MRI scanner

Intervention Type: RADIATION

PET/MRI Scan with \[18F\]DCFPyL as directed by protocol

Interventions

[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

Intervention Type: DRUG

PET/MRI scanner

PET/MRI Scan with \[18F\]DCFPyL as directed by protocol

Intervention Type: RADIATION

Other Intervention Names

positron emission tomography dye; magnetic resonance imaging

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ciprian Catana, MD, PhD

OTHER

Sponsor Role: lead

Responsible Party

Ciprian Catana, MD, PhD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ciprian Catana, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01CA218187

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-048

Identifier Type: -

Identifier Source: org_study_id