ACTIVE_NOT_RECRUITING

Multimodal Machine Learning Characterization of Solid Tumors

Conditions

Adenocarcinoma of Prostate Radical Prostatectomy Hepatocellular Carcinoma (HCC)Glioma Renal Cell Carcinoma (RCC)Prostate Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2022-10-23

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04687969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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

Inclusion Criteria

Exclusion 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.
* 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.

* 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

Contacts and Locations

Principal Investigator

Ciprian Catana, MD, Ph.D

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02115

United States

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Ciprian Catana, MD, PhD

Ciprian Catana, MD, Ph.D, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-23

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-10-23

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

Adenocarcinoma of Prostate
Radical Prostatectomy
Hepatocellular carcinoma (HCC)
Glioma
Renal Cell Carcinoma (RCC)
Prostate Cancer

Additional Relevant MeSH Terms

Adenocarcinoma of Prostate
Radical Prostatectomy
Hepatocellular Carcinoma (HCC)
Glioma
Renal Cell Carcinoma (RCC)
Prostate Cancer