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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.