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

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ClinicalTrials.gov Identifier: NCT03736564
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Drake, MD, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Osteomalacia Combination Product: 68Ga-DOTATATE PET/CT Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jad Sfeir, MD 507-284-2617 Sfeir.Jad@mayo.edu
Contact: Vishakantha (Vishu) Murthy, PhD 507-255-8112 Murthy.Vishakantha@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
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         
Sponsors and Collaborators
Mayo Clinic
Investigators
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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

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Responsible Party: Matthew Drake, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03736564     History of Changes
Other Study ID Numbers: 17-008120
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Matthew Drake, MD, Mayo Clinic:
FGF 23
oncogenic
tumor induced

Additional relevant MeSH terms:
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Osteomalacia
Neoplasms, Connective Tissue
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases