68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01524016
First received: January 29, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Oncogenic Osteomalacia
Mesenchymal Tumor
Drug: 68Ga-DOTATATE
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 68Ga-DOTATATE PET/CT for Detection and Evaluation of the Causative Tumor of Oncogenic Osteomalacia

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Number of participants and kinds of adverse events as a measure of safety [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Determine if any adverse effects are associated with the scan and the number of patients that experience them.


Estimated Enrollment: 30
Study Start Date: December 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 68Ga-DOTATATE, PET/CT scan
We will perform 68Ga-DOTATATE PET/CT scanning on subjects
Drug: 68Ga-DOTATATE
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01524016

Contacts
Contact: Fang Li, MD 86-10-65295502 lifang@pumch.cn
Contact: Zhaohui Zhu, MD, PhD 86-10-13611093752 zzh_1969@yahoo.com.cn

Locations
China
Department of Nuclear Medicine, Peking Union Medical College Hopital Recruiting
Beijing, China, 100730
Contact: Fang Li, MD    86-10-65295502    lifang@pumch.cn   
Contact: Zhaohui Zhu, MD, PhD    86-10-13611093752    zzh_1969@yahoo.com.cn   
Principal Investigator: Fang Li, MD         
Sub-Investigator: Zhaohui Zhu, MD, PhD         
Sub-Investigator: Hongli Jing, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Study Chair: Fang Li, MD Department of Nuclear Medicine, Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01524016     History of Changes
Other Study ID Numbers: PUMCHNM001
Study First Received: January 29, 2012
Last Updated: July 10, 2014
Health Authority: China: Ministry of Health

Keywords provided by Peking Union Medical College Hospital:
Oncogenic osteomalacia
mesenchymal tumor
Somatostatin receptor
68Ga-DOTATATE
PET/CT

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

ClinicalTrials.gov processed this record on July 28, 2014