Adenocarcinoma of ProstateNCT04687969
Multimodal Machine Learning Characterization of Solid Tumors
An observational study of Adenocarcinoma of Prostate and Radical Prostatectomy, run by Ciprian Catana, MD, PhD at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of Prostate, Radical Prostatectomy, Hepatocellular Carcinoma (HCC)
- What is being tested?
- [18F]DCFPyL and PET/MRI scanner
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2022to 12 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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:
Show all 10Show fewer
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: Multimodal PET/MRI Machine Learning Approaches for Characterization of Solid Tumors
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)
Read the 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
- Being tested
- [18F]DCFPyL, PET/MRI scanner
- Keywords
- Adenocarcinoma of Prostate, Radical Prostatectomy, Hepatocellular carcinoma (HCC), Glioma, Renal Cell Carcinoma (RCC), Prostate Cancer
- Medical subject headings
- Carcinoma, Hepatocellular, Glioma, Carcinoma, Renal Cell, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]DCFPyLDrug
Also called positron emission tomography dye
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 scannerRadiation
Also called magnetic resonance imaging
PET/MRI Scan with [18F]DCFPyL as directed by protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [18F]DCFPyL; Radiation: PET/MRI scanner | |
| 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 Receives: Drug: [18F]DCFPyL; Radiation: PET/MRI scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value of multimodal imaging in primary prostate cancer patients
First tumor aggressiveness will be identified by binarizing the Gleason grade scores (GG ≥ 3+4). Binarized tumor aggressiveness obtained from the machine learning techniques will be then compared to the gold-standard, histopathology.
Measured: 3 Days
Secondary outcomes (1)
Scan-rescan repeatability
Repeated measures analysis of covariance (ANCOVA) to evaluate statistical significance using a multilevel analysis to accommodate the nested structure of the data (longitudinal correlated data). Wilcoxon signed rank test will be used to assess for differences in each imaging parameter across visits. Spearman rank correlation will be used to test the correlation between [18F]-DCFPyL binding as measured by standardized uptake values (SUV) and Ktrans or SUV and cerebral blood flow (CBF). The false discovery rate will be used to adjust for multiple testing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start23 Oct 2022
- Primary completion12 Aug 2024
- Study completion12 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of ProstateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ciprian Catana, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Ciprian Catana, MD, PhD, Massachusetts General Hospital
- Investigators
- Ciprian Catana, MD, Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687969
- Sponsor's protocol ID
- 20-048
- Other IDs
- R01CA218187
- Status last verified
- May 2026
- First submitted
- 23 Dec 2020
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal PET/MRI Machine Learning Approaches for Characterization of Solid Tumors
- ClinicalTrials.gov ID
- NCT04687969
- Acronym / sponsor ID
- 20-048
- Conditions
- Adenocarcinoma of Prostate, Radical Prostatectomy, Hepatocellular Carcinoma (HCC), Glioma, Renal Cell Carcinoma (RCC), Prostate Cancer
- Keywords
- Adenocarcinoma of Prostate, Radical Prostatectomy, Hepatocellular carcinoma (HCC), Glioma, Renal Cell Carcinoma (RCC), Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ciprian Catana, MD, PhDUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Oct 2022 (actual)
- Primary completion
- 12 Aug 2024 (actual)
- Study completion
- 12 Aug 2024 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COHORT A: PROSTATE CANCER PATIENTS | – | Drug: [18F]DCFPyL, Radiation: PET/MRI scannerPrimary 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. |
| COHORT B: SOLID TUMOR PATIENTS | – | Drug: [18F]DCFPyL, Radiation: PET/MRI scannerPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- --- 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.
- Patient must be able to undergo MRI and PET scans.
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]DCFPyLAlso: positron emission tomography dyewill 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 | Drug | COHORT A: PROSTATE CANCER PATIENTS, COHORT B: SOLID TUMOR PATIENTS |
| PET/MRI scannerAlso: magnetic resonance imagingPET/MRI Scan with [18F]DCFPyL as directed by protocol | Radiation | COHORT A: PROSTATE CANCER PATIENTS, COHORT B: SOLID TUMOR PATIENTS |
Primary outcome
Diagnostic value of multimodal imaging in primary prostate cancer patients
Time frame: 3 Days
First tumor aggressiveness will be identified by binarizing the Gleason grade scores (GG ≥ 3+4). Binarized tumor aggressiveness obtained from the machine learning techniques will be then compared to the gold-standard, histopathology.
1 secondary outcome
Scan-rescan repeatability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Adenocarcinoma of Prostate
Not yet recruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruitingPhase 3
Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer
Prostate Cancer, Prostate Adenocarcinoma
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingPhase 2
Placebo-Controlled Trial of Urolithin A Supplementation in Men With Prostate Cancer Undergoing Radical Prostatectomy, URO-PRO Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ciprian Catana, MD, Ph.D principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma of Prostate and Radical Prostatectomy, run by Ciprian Catana, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value of multimodal imaging in primary prostate cancer patients (time frame: 3 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.