Multimodal Machine Learning Characterization of Solid Tumors

Recruiting

• Conditions: Adenocarcinoma of Prostate; Radical Prostatectomy; Hepatocellular Carcinoma (HCC); Glioma; Renal Cell Carcinoma (RCC); Prostate Cancer
• Interventions: Drug: [18F]DCFPyL; Radiation: PET/MRI scanner

• Registration Number: NCT04687969
• Lead Sponsor: Ciprian Catana, MD, PhD

Brief 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)

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 Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Study Start: 2022-10-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COHORT A: PROSTATE CANCER PATIENTS	PET/MRI scanner	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.
COHORT B: SOLID TUMOR PATIENTS	[18F]DCFPyL	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
COHORT B: SOLID TUMOR PATIENTS	PET/MRI scanner	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
COHORT A: PROSTATE CANCER PATIENTS	[18F]DCFPyL	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic value of multimodal imaging in primary prostate cancer patients	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.

Secondary Outcome Measures

Name	Time	Method
Scan-rescan repeatability	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.

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth-Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States