Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03736564|
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteomalacia||Combination Product: 68Ga-DOTATATE PET/CT||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga-DOTATATE PET for Localization of Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia|
|Actual Study Start Date :||January 31, 2019|
|Estimated Primary Completion Date :||June 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: 68Ga-DOTATATE PET/CT
Subjects will undergo imaging by 68Ga-DOTATATE PET/CT
Combination Product: 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736564
|Contact: Jad Sfeir, MD||507-284-2617||Sfeir.Jad@mayo.edu|
|Contact: Vishakantha (Vishu) Murthy, PhD||507-255-8112||Murthy.Vishakantha@mayo.edu|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Jad Sfeir, MD 507-284-2617 Sfeir.Jad@mayo.edu|
|Contact: Vishakantha (Vishu) Murthy, PhD 507-255-8112 Murthy.Vishakantha@mayo.edu|
|Principal Investigator: Matthew Drake, MD|
|Sub-Investigator: Stephen M Broski, MD|
|Sub-Investigator: Peter Tebben, MD|
|Sub-Investigator: Jad Sfeir, MD|
|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|