Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
Primary Purpose
Osteomalacia
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
68Ga-DOTATATE PET/CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Osteomalacia focused on measuring FGF 23, oncogenic, tumor induced
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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-DOTATATE PET/CT
Arm Description
Subjects will undergo imaging by 68Ga-DOTATATE PET/CT
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03736564
Brief Title
Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
Official Title
68Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 31, 2019 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteomalacia
Keywords
FGF 23, oncogenic, tumor induced
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
68Ga-DOTATATE PET/CT
Arm Type
Experimental
Arm Description
Subjects will undergo imaging by 68Ga-DOTATATE PET/CT
Intervention Type
Combination Product
Intervention Name(s)
68Ga-DOTATATE PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
68Ga-DOTATATE PET Positive Maximum Intensity Projection
Description
68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Drake, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen M Broski, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Tebben, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jad Sfeir, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
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