NCT04763109 Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
| NCT ID | NCT04763109 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nicole Baca |
| Condition | Neurofibromatosis Type 1 |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2022-07-08 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2022-07-08 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single arm pilot trial of a novel whole-body Magnetic Resonance Imaging paired with artificial intelligence intervention, to evaluate feasibility defined as scan-rescan reliability, and to estimate the positive predictive value of changes in Magnetic Resonance Imaging scans from baseline to 12-month visit using an Artificial Intelligence algorithm, among 15 pediatric patients with neurofibromatosis type 1 at Cedars-Sinai Medical Center.
Eligibility Criteria
Inclusion Criteria: * Between the ages of 5 and \<18 years at the start of study. If subject will turn 18 during the study, they will be allowed to enroll. * Clinically or molecularly confirmed diagnosis of NF-1. Subjects with mosaic/segmental NF-1 also qualify for the study. Exclusion Criteria: * Requiring sedation for imaging. * Implants and/or Devices: Mechanical, magnetic or electrical activated implants; Ferromagnetic implants and foreign bodies * Claustrophobia, problems being in enclosed spaces, or inability to lie facing upwards. * Allergy to animal dander or animal-instigated asthma.
Contact & Investigator
Nicole Baca, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT04763109 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Neurofibromatosis Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04763109 currently recruiting?
Yes, NCT04763109 is actively recruiting participants. Contact the research team at GroupCancerTrialInformation@cshs.org for enrollment information.
Where is the NCT04763109 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT04763109 clinical trial?
NCT04763109 is sponsored by Nicole Baca. The principal investigator is Nicole Baca, MD at Cedars-Sinai Medical Center. The trial plans to enroll 15 participants.