Ga-DOTATATE PET Imaging for Osteomalacia

Overseen By Jad Sfeir, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnant, Prisoners, Heritable rickets, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The researchers are trying to evaluate a newer imaging technique (Ga-DOTATATE PET/CT) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.

Research Team

Matthew Drake, MD

Principal Investigator

Mayo Clinic

Stephen M Broski, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 18 who have been seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 2000 and 2018. Participants must consent to the study. It excludes prisoners, pregnant individuals, those with heritable forms of the condition or those who've already had successful tumor localization and resection.

Inclusion Criteria

I am an adult who was treated for FGF23 related bone disease at Mayo Clinic, Rochester between 2000 and 2018 and agree to join the study.

Exclusion Criteria

Prisoners

My tumor was successfully located and removed.

Subjects who do not consent for the study or withdraw consent during the duration of the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo 68Ga-DOTATATE PET/CT imaging to localize phosphaturic mesenchymal tumors

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, with results discussed by the endocrinologist

1 year

Follow-up visit or phone call

Treatment Details

Interventions

• 68Ga-DOTATATE PET/CT

Trial Overview The trial evaluates a new imaging technique called Ga-DOTATATE PET/CT to see if it's better at finding where the hormone causing low phosphate levels in patients with osteomalacia is coming from.

Participant Groups

Group I: 68Ga-DOTATATE PET/CT Experimental Treatment 1 Intervention

Subjects will undergo imaging by 68Ga-DOTATATE PET/CT

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+