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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a diagnosis of Fanconi Anemia who are willing to participate and willing to have MRIs

Willing to provide informed consent

Disqualifiers

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

Trial population

Patients with Fanconi anemia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MRIs

    Diagnostic test

    mMRI and ddMRI

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: FA patients with a history of HNSCC1 intervention
Group B: FA patients with no history of HNSCC1 intervention

Trial outcomes

Primary outcomes

1

sensitivity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.

Proportion of positive lesions correctly diagnosed

Time frame
Immediately after MRI
2

specificity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.

Proportion of negative lesions correctly diagnosed

Time frame
Immediately after MRI

Secondary outcomes

Other outcomes

Sponsors and contacts

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