Fanconi AnemiaNCT07649031
MRI as Noninvasive Innovative Approach in Detection and Monitoring of Malignant Oral Lesions in Fanconi Anemia Patients
An observational study of Fanconi Anemia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fanconi Anemia
- What is being tested?
- MRIs
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2026to 31 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Fanconi anemia
Who may be able to join
- Patients with a diagnosis of Fanconi Anemia who are willing to participate and willing to have MRIs
- Willing to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Carla Campbell, BS, 612-625-6976, camp2757@umn.edu
About this study
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
- Being tested
- MRIs
- Medical subject headings
- Fanconi Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIsDiagnostic test
mMRI and ddMRI
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Diagnostic Test: MRIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.
Proportion of positive lesions correctly diagnosed
Measured: Immediately after MRI
specificity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.
Proportion of negative lesions correctly diagnosed
Measured: Immediately after MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start23 Jun 2026
- Primary completion31 May 2030 (estimated)
- Study completion31 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fanconi AnemiaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Uppgaard, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649031
- Sponsor's protocol ID
- DENT-2025-34242, STUDY00027283
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI as Noninvasive Innovative Approach in Detection and Monitoring of Malignant Oral Lesions in Fanconi Anemia Patients
- ClinicalTrials.gov ID
- NCT07649031
- Acronym / sponsor ID
- DENT-2025-34242, STUDY00027283
- Conditions
- Fanconi Anemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FA patients with a history of HNSCC | – | Diagnostic Test: MRIsThis group will receive both mMRI and ddMRI, with an exam, every 3-4 months for 2 years (up to 16 scan (+exam) visits). |
| FA patients with no history of HNSCC | – | Diagnostic Test: MRIsThis group will receive two scans each of mMRI and ddMRI, with an exam, one year apart (up to 4 scan (+exam) visits). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Fanconi anemia
Key inclusion criteria (2 listed)
- Patients with a diagnosis of Fanconi Anemia who are willing to participate and willing to have MRIs
- Willing to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIsmMRI and ddMRI | Diagnostic test | FA patients with a history of HNSCC, FA patients with no history of HNSCC |
Primary outcome
sensitivity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.
Time frame: Immediately after MRI
Proportion of positive lesions correctly diagnosed
specificity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients.
Time frame: Immediately after MRI
Proportion of negative lesions correctly diagnosed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
Related trials for Fanconi Anemia
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
Glycogen Storage Disease Type IA, Glycogen Storage Disease Type I
RecruitingPhase 1
Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia
Fanconi Anemia, Head and Neck Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Uppgaard principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fanconi Anemia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla Campbell, BS (612-625-6976, camp2757@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of mMRI and ddMRI in identifying dysplastic and malignant lesions in FA patients. (time frame: Immediately after MRI). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.