AI and PET scans join forces to grade cancer without a biopsy
NCT ID NCT04687969
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This completed study tested whether combining PET/MRI scans with machine learning could better assess how aggressive prostate cancer and other solid tumors are. Researchers enrolled 50 adults with prostate cancer, liver cancer, brain tumors, or kidney cancer. The goal was to see if this imaging approach could match or replace the standard method of grading tumors through tissue samples (biopsy).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- [18F]DCFPyL (a radioactive dye for PET scans)
- What this could lead to
- If successful, this could lead to more accurate, non-invasive ways to determine tumor aggressiveness, potentially reducing the need for biopsies.
- What could go wrong
- This is a small, early-stage observational study focused on imaging methods, not a treatment. The machine learning approach may not prove reliable enough for widespread clinical use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
50 people
The number who actually took part.
- Started
-
Oct 2022
- Finished
-
Aug 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adenocarcinoma of prostate are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets
- Experimental therapy aims to turn brain tumors against themselves
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can two immunotherapy drugs make liver tumors more vulnerable to surgery?