Multimodal Machine Learning Characterization of Solid Tumors

Launched by CIPRIAN CATANA, MD, PHD · Dec 23, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on improving how we understand and assess the aggressiveness of certain types of solid tumors, especially prostate cancer. Researchers are using advanced imaging techniques, specifically a combination of a special type of PET scan and MRI, to gather more accurate information about these cancers. This study aims to help doctors make better decisions about treatment options by seeing how the tumors behave in detail.

To participate, you must be at least 18 years old and have a diagnosis of primary prostate cancer that requires surgery, or you may have other specific types of tumors like hepatocellular carcinoma (HCC), glioma, or renal cell carcinoma (RCC). Participants will undergo scans using these advanced imaging methods, which will help researchers gather important data. It’s important to note that some individuals may not be eligible due to factors like certain medical devices in their bodies, allergies to the imaging agents used, or if they are pregnant. If you qualify and decide to join, you’ll play a vital role in advancing our understanding of these cancers and improving future treatments.

Gender

ALL

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