MRI as Noninvasive Innovative Approach in Detection and Monitoring of Malignant Oral Lesions in Fanconi Anemia Patients

This study being done to learn more about the use of medical Magnetic Resonance Imaging (mMRI) and dedicated dental MRI (ddMRI) as a non-invasive diagnosing tool when evaluating potential oral cancerous and precancerous lesions in Fanconi Anemia patients.

Study Overview

• Status: Recruiting
• Conditions: Fanconi Anemia
• Intervention / Treatment: Diagnostic test: MRIs

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Carla Campbell, BS; Phone Number: 612-625-6976; Email: camp2757@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Carla Campbell, BS; Phone Number: 612-625-6976; Email: camp2757@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with Fanconi anemia

Description

Inclusion Criteria:

• Patients with a diagnosis of Fanconi Anemia who are willing to participate and willing to have MRIs
• Willing to provide informed consent

Exclusion Criteria:

• Patient without diagnosis of FA
• Patients with FA who are under the age of 18
• Unable to tolerate any MRI due to claustrophobia
• Any contraindication for the MRI
• Unable to provide informed consent or comply with the study protocol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
FA patients with a history of HNSCC; This group will receive both mMRI and ddMRI, with an exam, every 3-4 months for 2 years (up to 16 scan (+exam) visits).	Diagnostic test: MRIs; mMRI and ddMRI
FA patients with no history of HNSCC; This group will receive two scans each of mMRI and ddMRI, with an exam, one year apart (up to 4 scan (+exam) visits).	Diagnostic test: MRIs; mMRI and ddMRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.	Proportion of positive lesions correctly diagnosed	Immediately after MRI
specificity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.	Proportion of negative lesions correctly diagnosed	Immediately after MRI

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Rachel Uppgaard, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): May 25, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Genetic Diseases, Inborn; Metabolic Diseases; Hematologic Diseases; Bone Marrow Diseases; Anemia; DNA Repair-Deficiency Disorders; Anemia, Hypoplastic, Congenital; Anemia, Aplastic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Fanconi Anemia
• Other Study ID Numbers: DENT-2025-34242

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No