Al18F-NOTA-LM3 PET/CT in Patients With TIO

Application of Al18F-NOTA-LM3 PET/CT in the Diagnosis and Evaluation of Tumor-Induced Osteomalacia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07366099

Enrollment

Registered

2026-01-26

Start date

2023-03-30

Completion date

2026-05-30

Last updated

2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor-Induced Osteomalacia

Brief summary

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

DRUGDiagnostic 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.

DRUGDiagnostic 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic value	From study completion to 6 months after completion.	Sensitivity and specificity of Al18F-NOTA-LM3 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT

Secondary

Measure	Time frame	Description
standardized uptake value (SUV) of tumor	From study completion to 6 months after completion.	Compare the SUVmax of tumor derived from Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT.

Countries

China

Contacts

CONTACTHongli Jing

annsmile1976@sina.com18600586399

CONTACTYuwei Zhang

ywzhangwork@163.com18511071577

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026