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

NCT07649031 | Recruiting

• 1 other identifier: DENT-2025-34242
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fanconi Anemia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

MRIs DIAGNOSTIC_TEST

mMRI and ddMRI

FA patients with a history of HNSCC; FA patients with no history of HNSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Fanconi anemia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Fanconi Anemia

Condition Hierarchy (Ancestors)

Anemia, Hypoplastic, Congenital; Anemia, Aplastic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital Bone Marrow Failure Syndromes; Bone Marrow Failure Disorders; Bone Marrow Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Rachel Uppgaard

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Campbell, BS

CONTACT

612-625-6976; camp2757@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 31, 2030
• Study Completion (Estimated): May 31, 2030
• Last Updated: June 15, 2026

Record last verified: 2026-06

Locations

US (1)