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

Study Overview
=================
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.

Official Title
-----------------
68Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia

Conditions
-----------------
Osteomalacia

Intervention / Treatment
-----------------
* Combination Product: 68Ga-DOTATATE PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTATATE PET/CT<br>Subjects will undergo imaging by 68Ga-DOTATATE PET/CT | Combination Product: 68Ga-DOTATATE PET/CT<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 68Ga-DOTATATE PET Positive Maximum Intensity Projection | 68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs). | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FGF 23, oncogenic, tumor induced