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68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia

Descriptive Information
Brief Title † 68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia
Official Title † 68Ga-DOTATATE PET/CT for Detection and Evaluation of the Causative Tumor of Oncogenic Osteomalacia
Brief Summary Oncogenic osteomalacia is rare disease predominantly caused by a small, somatostatin receptor positive mesenchymal tumor, which is frequently hidden in an unusual anatomical site and often goes undetected by conventional imaging. A permanent cure of the disease relies on exactly localizing the tumor and completely removing it. 68Ga-DOTATATE PET/CT is a novel scan that might have improved sensitivity and resolution specifically for somatostatin receptor positive tumors. The investigators will scan the suspicious and confirmed patients of oncogenic osteomalacia and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT to see if it improves patient care.
Detailed Description Oncogenic osteomalacia, or tumor-induced osteomalacia, is a rare, serious paraneoplastic syndrome. It is predominantly driven by a small, benign mesenchymal tumor. The disease is readily prompted by the clinical features such as hyperphosphaturia, hypophosphatemia, low serum vitamin D3 levels, elevated serum fibroblast growth factor 23 levels, and osteomalacia. However, the causative tumor is frequently hidden in an unusual anatomical site and often goes undetected by conventional imaging, such as computed tomography (CT), while a permanent cure of the disease will only rely on exact localization and completely removal of the tumor. Since mesenchymal tumors express somatostatin receptors (SSR), molecular imaging using radiolabeled somatostatin analogs may be one of the best ways to detect the small, occult tumors. 111In- and 99mTc-labeled octreotide and analogs have been proved useful to detect mesenchymal tumor and other SSR-positive tumors. However, the scintigraphy is insufficient to provide high-resolution images and precise anatomical information. In this study, a novel approach was proposed for exact localization of mesenchymal tumors through positron emission tomography (PET) imaging with 68Ga-DOTATATE and co-registration with CT. 68Ga-DOTATATE PET/CT is a novel method that might have improved sensitivity and resolution specifically for SSR-positive tumors, including the causative tumor of oncogenic osteomalacia. The investigators will scan the patients in suspicion of oncogenic osteomalacia and the confirmed oncogenic osteomalacia patients in suspicion of relapse or with residual tumor after surgery, and compare it to 99mTc-HYNIC-TOC SPECT/CT and 18F-FDG PET/CT of the same patients. The aim of the study was to see if 68Ga-DOTATATE PET/CT can detect more tumors with higher resolution and more exact localization, and then help to develop optimal treatment strategy and improves patient care.
Study Phase Early Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Number and location of lesions detected by 68GA-DOTATATE PET/CT compared to 99mTc-HYNIC-TOC SPECT/CT and/or 18F-FDG PET/CT
Secondary Outcome Measure † Number of participants and kinds of adverse events as a measure of safety
Condition † Oncogenic Osteomalacia Mesenchymal Tumor
Intervention † Drug68Ga-DOTATATE
Study Arms / Comparison Groups 68Ga-DOTATATE, PET/CT scan We will perform 68Ga-DOTATATE PET/CT scanning on subjects
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 100
Start Date † December 2011
Completion Date December 2017
Primary Completion Date December 2017
Eligibility Criteria † Inclusion Criteria: - In suspicion of oncogenic osteomalacia according to the clinical features such as hyperphosphaturia, hypophosphatemia, low serum vitamin D3 levels, and osteomalacia. Or prior oncogenic osteomalacia patients in suspicion of relapse or with residual tumor - At least 18 years old - Able to provide informed consent Exclusion Criteria: - Females planning to bear a child recently or with childbearing potential - Renal function: serum creatinine >3.0 mg/dL (270 μM/L) - Liver function: any hepatic enzyme level more than 5 times upper limit of normal. - Known severe allergy or hypersensitivity to IV radiographic contrast. - Patients not able to enter the bore of the PET/CT scanner. - Inability to lie still for the entire imaging time because of cough, pain, etc. - Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. - Any other medical condition that, in the opinion of the Investigator, may significantly interfere with study compliance.
Gender All
Ages 18 Years - 70 Years
Accepts Healthy Volunteers No
Contacts †† Fang Li, MD, 86-10-65295502, lifang@pumch.cn
Location Countries † China
Administrative Information
NCT ID † NCT01524016
Organization ID PUMCHNM001
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Peking Union Medical College Hospital
Collaborators ††
Investigators † Study Chair: Fang Li, MD, Department of Nuclear Medicine, Peking Union Medical College Hospital
Information Provided By
Verification Date July 2014
First Received Date † January 29, 2012
Last Updated Date April 5, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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