Clinical trial · Interventional
68Ga-DOTATATE PET/CT in Oncogenic Osteomalacia
68Ga-DOTATATE PET/CT for Detection and Evaluation of the Causative Tumor of Oncogenic Osteomalacia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesenchymal Tumor | Mesenchymal Cell Neoplasm | ALIAS | 0.90 |
| Oncogenic Osteomalacia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTATATE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTATATE, PET/CT scan
- description
- We will perform 68Ga-DOTATATE PET/CT scanning on subjects
- interventionNames
- Drug: 68Ga-DOTATATE
Primary outcomes (1)
- 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
- timeFrame
- 1 year
- description
- 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 outcomes (1)
- measure
- Number of participants and kinds of adverse events as a measure of safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
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