Multimodal Machine Learning Characterization of Solid Tumors

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

This study is testing a new way to analyze solid tumors using advanced computer techniques to see if it can help doctors understand and treat cancer better.

Quick facts

• Study type: Observational
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT04687969 on ClinicalTrials.gov

What this trial studies

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Who should consider this trial

Good fit: Unknown

Not a fit: Unknown

Why it matters

Potential benefit: Unknown

How similar studies have performed: Unknown

Eligibility criteria

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

Where this trial is running

Boston, Massachusetts and 1 other locations

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Beth-Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Ciprian Catana, MD, Ph.D — Massachusetts General Hospital
• Study coordinator: Ciprian Catana, MD, Ph.D

Conditions Adenocarcinoma of Prostate; Radical Prostatectomy; Hepatocellular Carcinoma; Glioma; Renal Cell Carcinoma; Prostate Cancer; Hepatocellular carcinoma