- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03736564
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Jad Sfeir, MD
- Phone Number: 507-284-2617
- Email: Sfeir.Jad@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 68Ga-DOTATATE PET/CT
Subjects will undergo imaging by 68Ga-DOTATATE PET/CT
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
68Ga-DOTATATE PET Positive Maximum Intensity Projection
Time Frame: One year
|
68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).
|
One year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Matthew Drake, MD, Mayo Clinic
- Principal Investigator: Stephen M Broski, MD, Mayo Clinic
- Principal Investigator: Peter Tebben, MD, Mayo Clinic
- Principal Investigator: Jad Sfeir, MD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-008120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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