Multimodal Machine Learning Characterization of Solid Tumors

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    135
  • sponsor
    Ciprian Catana, MD, PhD
Updated on 7 October 2022
renal function
cancer
MRI
pet scan
renal function tests

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)

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.

Details
Condition Adenocarcinoma of Prostate, Radical Prostatectomy, Hepatocellular Carcinoma (HCC), Glioma, Renal Cell Carcinoma (RCC), Prostate Cancer
Treatment [18F]DCFPyL, PET/MRI scanner
Clinical Study IdentifierNCT04687969
SponsorCiprian Catana, MD, PhD
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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