68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital

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.