68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia
Conditions
Oncogenic Osteomalacia - Mesenchymal Tumor
Conditions: official terms
Neoplasms, Connective Tissue - Osteomalacia
Conditions: Keywords
Oncogenic osteomalacia, mesenchymal tumor, Somatostatin receptor, 68Ga-DOTATATE, PET/CT
Study Type
Interventional
Study Phase
Phase 0
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 68Ga-DOTATATE
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Department of Nuclear Medicine, Peking Union Medical College Hopital
Beijing, China
Status: Recruiting
Contact: Fang Li, MD - 86-10-65295502 - lifang@pumch.cn
Start Date
December 2011
Completion Date
February 2016
Sponsors
Peking Union Medical College Hospital
Source
Peking Union Medical College Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page