RECRUITING

An Observational Study On TheAccuracy Of Whole-Body Magnetic Resonance Imaging (Wb-Mri) ScreeningTo Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (WB-MRI) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites within the United States. Study subjects must meet a set of inclusion and exclusion criteria. Potential subjects arriving at the study sites will be evaluated for enrollment. It is the Principal Investigator's (PI) responsibility to enroll only subjects who satisfy the inclusion/exclusion criteria. Recruitment can occur by subject presentation at the sites for elective standard screening, word-of-mouth, flyers, healthcare professional (HCP) referrals, advertisement online, or any other means, subject to approval by the associated institutional review board (IRB) or ethics committee (EC) when applicable.

Official Title

A Multi-Site Prospective, Single-Arm, Observational Study On The Accuracy Of Whole Body Magnetic Resonance Imaging (Wb-Mri) Screening To Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.

Quick Facts

Study Start:2024-05-17
Study Completion:2037-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06212479

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Each subject MUST:
  2. * Be\>=18 years of age at the time of enrollment.
  3. * Be able to read and understand provided procedural information for the study;
  4. * Be able and willing to follow all study procedures including proper breathing and body movement minimization while within the WB-MRI system;
  5. * Be willing and able to provide required clinical, demographic, medical history, and concomitant medications information;
  6. * Be able to provide financial payment in advance for reimbursement of the cost of the WBMRI acquisition procedure and interpretation;
  7. * Complete all required consent procedures.
  1. * Harbor within their bodies contraindicated medical devices including, but not limited to, implanted pacemakers, intracranial aneurysm clips, cochlear implants, drug infusion pumps, neurostimulators, bone growth stimulators, certain intrauterine contraceptive devices, non- MRI safe metals, etc.;
  2. * Self-certify that they are pregnant;
  3. * Be seeking to undergo WB-MRI as a subject in this study in lieu of other covered dedicated diagnostic imaging evaluations when such covered procedures represent more appropriate or standard-of-care procedures by context-specific clinical indication;
  4. * Be an employee of the study site or the sponsor;
  5. * Have a medical condition or serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.

Contacts and Locations

Study Contact

Gerimar Leon, BS
CONTACT
(617) 362-3570
gerimar.leon@herculesstudy.org.com
Sarah Hemeon, BS
CONTACT
(617) 203-7565
sarah.hemeon@herculesstudy.org.com

Principal Investigator

Perry Kaneriya, MD, MBA
PRINCIPAL_INVESTIGATOR
Hercules
Pratik Shingru, MBBS, MPH
STUDY_DIRECTOR
Hercules research center

Study Locations (Sites)

Hercules Research Center
Watertown, Massachusetts, 02472
United States

Collaborators and Investigators

Sponsor: Hercules

  • Perry Kaneriya, MD, MBA, PRINCIPAL_INVESTIGATOR, Hercules
  • Pratik Shingru, MBBS, MPH, STUDY_DIRECTOR, Hercules research center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-17
Study Completion Date2037-01

Study Record Updates

Study Start Date2024-05-17
Study Completion Date2037-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cancer
  • Metabolic Disease
  • Aneurysm
  • Neurologic Disorder