• Follow
  • Follow
  • Follow
  • Follow
U

Search



Shop

w

News

w

Blog

DONATE
Team Jack Foundation
  • About Us
    • Our Mission
    • Jack Hoffman
    • Board & Staff
    • Financials
  • Our Impact
    • Scientific Advisory Board
    • Sponsored Grants
    • Research Articles
  • Brain Cancer
    • What is Brain Cancer?
      • What is DIPG?
    • Brain Cancer Facts
    • Cancer Awareness Months
      • Brain Tumor Awareness Month
    • Family Resources
  • Events
  • Get Involved
    • Fundraise
      • Host an Event
      • Run For Team Jack
      • Birthday Fundraiser
    • Give
    • Our Sponsors
    • Volunteer
  • Heroes
  • Donate
  • Shop
  • Blog
  • News
Select Page

Get Involved

Clinical Trial Finder

Search Results

Multimodal Machine Learning Characterization of Solid Tumors

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04687969
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ciprian Catana, MD, PhD
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ciprian Catana, MD, Ph.D
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Adenocarcinoma of Prostate, Radical Prostatectomy, Hepatocellular Carcinoma (HCC), Glioma, Renal Cell Carcinoma (RCC), Prostate Cancer
Additional Details

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.

Arms & Interventions

Arms

: 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.

: 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

Interventions

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

Radiation: - PET/MRI scanner

PET/MRI Scan with [18F]DCFPyL as directed by protocol

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Massachusetts General Hospital

Boston 4930956, Massachusetts 6254926, 02115

Site Contact

Ciprian Catana, MD, Ph.D

[email protected]

617-643-4885

Beth-Israel Deaconess Medical Center, Boston 4930956, Massachusetts 6254926

Status

Not yet recruiting

Address

Beth-Israel Deaconess Medical Center

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

[email protected]

617-643-4885

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

Make an impact through your inbox

News, upcoming events and research updates delivered straight to your inbox.

  • This field is for validation purposes and should be left unchanged.
MAKE AN IMPACT

Donate today to help the Team Jack Foundation fund research and fight pediatric brain cancer.

Make a Donation
  • About Us
  • Our Mission
  • Jack Hoffman
  • Board & Staff
  • Fund Allocation
  • Financials
  • Our Impact
  • Scientific Advisory Board
  • Sponsored Grants
  • Research Articles
  • Brain Cancer
  • Family Resources
  • Get Involved
  • Fundraise
  • Give
  • Events
  • Our Sponsors
  • Volunteer
  • Follow
  • Follow
  • Follow
  • Follow
  • Follow
seal of transparency badge - 2019 Gold
combined health agencies drive member charity badge
Share Omaha member badge
© 2021 Team Jack Foundation. PO Box 607, Atkinson, NE, 68713. All Rights Reserved. Team Jack Foundation, Inc. is exempt from federal income tax under section 501(c)3, ID Number 46-2301134, of the internal revenue code. All contributions to the Foundation are tax deductible. Privacy Policy • Contact