68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia
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|ClinicalTrials.gov Identifier: NCT01524016|
Recruitment Status : Unknown
Verified July 2014 by gwcmc.
Recruitment status was: Recruiting
First Posted : February 1, 2012
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Oncogenic Osteomalacia Mesenchymal Tumor||Drug: 68Ga-DOTATATE||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||68Ga-DOTATATE PET/CT for Detection and Evaluation of the Causative Tumor of Oncogenic Osteomalacia|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: 68Ga-DOTATATE, PET/CT scan
We will perform 68Ga-DOTATATE PET/CT scanning on subjects
Intravenous injection of one dosage of 72-185MBq (2-5 mCi) 68Ga-DOTATATE solution. Tracer doses of 68Ga-DOTATATE will be used to image tumors by Positron Emission Tomography / computed tomography (PET/CT)
Other Name: (68)Ga-DOTA-d-Phe(1),Tyr(3)-octreotate
- Number and location of lesions detected by 68GA-DOTATATE PET/CT compared to 99mTc-HYNIC-TOC SPECT/CT and/or 18F-FDG PET/CT [ Time Frame: 1 year ]Determine if the 68Ga-DOTATATE PET/CT changes care plans compared to conventional imaging/diagnostic techniques (99mTc-HYNIC-TOC SPECT/CT, and/or 18F-FDG PET/CT, MRI, CT, ultrasonography).
- Number of participants and kinds of adverse events as a measure of safety [ Time Frame: One year ]Determine if any adverse effects are associated with the scan and the number of patients that experience them.
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): NCT01524016
|Contact: Fang Li, MDfirstname.lastname@example.org|
|Contact: Zhaohui Zhu, MD, PhDemail@example.com|
|Department of Nuclear Medicine, Peking Union Medical College Hopital||Recruiting|
|Beijing, China, 100730|
|Contact: Fang Li, MD 86-10-65295502 firstname.lastname@example.org|
|Contact: Zhaohui Zhu, MD, PhD 86-10-13611093752 email@example.com|
|Principal Investigator: Fang Li, MD|
|Sub-Investigator: Zhaohui Zhu, MD, PhD|
|Sub-Investigator: Hongli Jing, MD|
|Study Chair:||Fang Li, MD||Department of Nuclear Medicine, Peking Union Medical College Hospital|