Fact CheckerSign in

NCT04687969Completed

Multimodal Machine Learning Characterization of Solid Tumors

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

Source: ClinicalTrials.gov · Last updated 22 May 2026

Brief summary (registry, in English)

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)

Status (registry)
Completed
Study type
Observational
Enrollment
50 (actual)
First submitted
23 Dec 2020
Start date
23 Oct 2022
Primary completion date
12 Aug 2024
Lead sponsor
Ciprian Catana, MD, PhD
NCT number
NCT04687969

What you commit to

  • Study type: Observational
  • Participants enrolled: 50
  • From 23 Oct 2022 to the primary completion date, 12 Aug 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the PET radiotracer, \[18F\]DCFPyL.

Lab values

  • 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

Other

  • Participants determined by the investigator(s) to be clinically unsuitable for the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.