Clinical trial NCT04687969: Multimodal Machine Learning Characterization of Solid Tumors
Official title: Multimodal PET/MRI Machine Learning Approaches for Characterization of Solid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenocarcinoma of Prostate
Radical Prostatectomy
Hepatocellular Carcinoma (HCC)
Glioma
Renal Cell Carcinoma (RCC)
Prostate Cancer
Keywords: Adenocarcinoma of Prostate
Radical Prostatectomy
Hepatocellular carcinoma (HCC)
Glioma
Renal Cell Carcinoma (RCC)
Prostate Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-12-29
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Diagnostic value of multimodal imaging in primary prostate cancer patients
timeFrame: 3 Days
Secondary outcomes:
measure: Scan-rescan repeatability
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth-Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ciprian Catana, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: