Multimodal Machine Learning Characterization of Solid Tumors

March 12, 2024 updated by: Ciprian Catana, MD, PhD

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Ciprian Catana, MD, Ph.D
        • Principal Investigator:
          • Ciprian Catana, MD, Ph.D
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth-Israel Deaconess Medical Center
        • Principal Investigator:
          • Maria-Andreea Catana, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: [18F]DCFPyL
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
Other Names:
  • positron emission tomography dye
Radiation: PET/MRI scanner
PET/MRI Scan with [18F]DCFPyL as directed by protocol
Other Names:
  • magnetic resonance imaging
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
Drug: [18F]DCFPyL
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
Other Names:
  • positron emission tomography dye
Radiation: PET/MRI scanner
PET/MRI Scan with [18F]DCFPyL as directed by protocol
Other Names:
  • magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scan-rescan repeatability
Time Frame: 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ciprian Catana, MD, PhD

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ciprian Catana, MD, Ph.D, 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 Major Dates

Study Start (Actual)

October 23, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-048
  • R01CA218187 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Partners Innovations team at http://www.partners.org/innovation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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