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This is a pilot study to assess the value of whole-body Al18F-NOTA-LM3 PET/CT in patients with tumor-induced osteomalacia.
Tumor-induced osteomalacia (TIO) is a rare paraneoplastic syndrome. The main cure for TIO is surgical removal of the responsible tumor. Somatostatin receptors (SSTR) targeted PET imaging with radiolabeled somatostatin analogs can help locate these tumors. It can detect culprit tumors in TIO patients, even small ones that CT or MRI might miss. 68Ga-DOTATATE is the most commonly used SSTR PET tracer for TIO, recommended as the first-line imaging tool to find the causative tumor.
Compared to 68Ga-based tracers, 18F-labelled radiotracers offer several advantages, including higher cyclotron production, lower positron energy, and longer half-life. These features may improve image quality. Al18F-NOTA-LM3 is an SSTR2 specific antagonist used as a PET tracer. This pilot study is designed to compare Al18F-NOTA-LM3 with 68Ga-DOTATATE in the same group of TIO patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan | Experimental | Patients of TIO PET/CT imaging: Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic Test: Al18F-NOTA-LM3 | Drug | Al18F-NOTA-LM3 will be injected into the patients. Patients will undergo a whole-body PET/CT scan 60-120 minutes after injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value | Sensitivity and specificity of Al18F-NOTA-LM3 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT | From study completion to 6 months after completion. |
| Measure | Description | Time Frame |
|---|---|---|
| standardized uptake value (SUV) of tumor | Compare the SUVmax of tumor derived from Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT. | From study completion to 6 months after completion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Jing | Contact | 18600586399 | annsmile1976@sina.com | |
| Yuwei Zhang | Contact | 18511071577 | ywzhangwork@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| C537751 | Oncogenic osteomalacia |
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| Diagnostic Test: 68Ga-DOTATATE | Drug | 68Ga-DOTATATE will be injected into the patients. Patients will undergo a whole-body PET/CT scan 40-60 minutes after injection. |
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