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NCT Number: NCT07366099

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

This is a pilot study to assess the value of whole-body Al18F-NOTA-LM3 PET/CT in patients with tumor-induced osteomalacia.

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Key information

Conditions

Tumor-Induced Osteomalacia Oncogenic osteomalacia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Hongli Jing

CONTACT

[email protected]

18600586399

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Diagnostic value

    Time frame: 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 outcomes

  1. standardized uptake value (SUV) of tumor

    Time frame: From study completion to 6 months after completion.

    Compare the SUVmax of tumor derived from Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT.

Study contacts

Contact information is provided by the study sponsor or research team.

Hongli Jing

CONTACT

[email protected]

18600586399

Yuwei Zhang

CONTACT

[email protected]

18511071577

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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