Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
68Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
2 other identifiers
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedStudy Start
First participant enrolled
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedResults Posted
Study results publicly available
April 30, 2025
CompletedApril 30, 2025
April 1, 2025
4.8 years
October 30, 2018
March 24, 2025
April 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs)
68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).
One year
Study Arms (1)
68Ga-DOTATATE PET/CT
EXPERIMENTALSubjects will undergo imaging by 68Ga-DOTATATE PET/CT
Interventions
Gallium-68 Dotatate, a radioactive imaging agent, is injected into a vein. Subjects will rest for approximately 50 minutes, after which approximately a 30 minute image of subjects body will be completed via PET/CT scan.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Stephen Broski
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Drake, MD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Stephen M Broski, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2018
First Posted
November 9, 2018
Study Start
January 31, 2019
Primary Completion
October 31, 2023
Study Completion
October 31, 2023
Last Updated
April 30, 2025
Results First Posted
April 30, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share