Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia

Phase 1

Completed

• Conditions: Osteomalacia
• Interventions: Combination Product: 68Ga-DOTATATE PET/CT

• Registration Number: NCT03736564
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Subjects will be contacted (phone script attached) to inform them of the study and the imaging modality. The first 10 patients that agree to participate in the study will be asked to present to the Mayo Clinic where they can provide a written consent and perform the imaging study.

Enrolled subjects will be evaluated in the clinical practice prior to having 68Ga-DOTATATE PET/CT imaging performed. The treating endocrinologist will be informed of the imaging results and will review the results with the subject using a follow-up visit or phone call; when a tumor is localized, the endocrinologist will discuss appropriate management options.

Subjects will be follow for one year post 68Ga-DOTATATE PET/CT.

Study Timeline

• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-09
• Study Start: 2019-01-31
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Results First Submitted: 2025-03-24
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Results First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Adults (18 years of age or older) seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 1/1/2000 and 1/30/2018 who provide informed consent to participate in the study.

Exclusion Criteria

• Pregnant
• Prisoners
• Subjects diagnosed with heritable hypophosphatemic rickets/osteomalacia
• Subjects who do not consent for the study or withdraw consent during the duration of the study.
• Subjects in whom tumor localization and successful resection has already occurred.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs)	One year	68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States