Al18F-NOTA-LM3 PET/CT in Patients With TIO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic Test: Al18F-NOTA-LM3, Diagnostic Test: 68Ga-DOTATATE.
- Who it may be relevant to
- Registry conditions: Tumor-Induced Osteomalacia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Application of Al18F-NOTA-LM3 PET/CT in the Diagnosis and Evaluation of Tumor-Induced Osteomalacia
Overview
This is a pilot study to assess the value of whole-body Al18F-NOTA-LM3 PET/CT in patients with tumor-induced osteomalacia.
Detailed description
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.
Interventions
- Drug Diagnostic Test: Al18F-NOTA-LM3
Al18F-NOTA-LM3 will be injected into the patients. Patients will undergo a whole-body PET/CT scan 60-120 minutes after injection. - Drug Diagnostic Test: 68Ga-DOTATATE
68Ga-DOTATATE will be injected into the patients. Patients will undergo a whole-body PET/CT scan 40-60 minutes after injection.
Primary outcome measures
- Diagnostic value [Time frame: From study completion to 6 months after completion.]
Secondary outcome measures (1)
- standardized uptake value (SUV) of tumor [Time frame: From study completion to 6 months after completion.]
Eligibility criteria
Inclusion criteria
- Patients aged 18 to 80 years.
- Suspected or confirmed TIO patients.
Exclusion criteria
- Combined with other types of tumors.
- Severe liver or renal dysfunction (ALT/AST≥5 ULN, GFR<30ml/min).
- Pregnant or breast-feeding women.
- Inability to perform PET/CT scans.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07366099 · ALFLM3TIO