NCT07366099

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Mar 2023May 2026

Study Start

First participant enrolled

March 30, 2023

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

January 26, 2026

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

January 18, 2026

Last Update Submit

January 18, 2026

Conditions

Tumor-Induced Osteomalacia

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • standardized uptake value (SUV) of tumor

    From study completion to 6 months after completion.

Study Arms (1)

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.

Drug: Diagnostic Test: Al18F-NOTA-LM3Drug: Diagnostic Test: 68Ga-DOTATATE

Interventions

Diagnostic Test: 68Ga-DOTATATEDRUG

68Ga-DOTATATE will be injected into the patients. Patients will undergo a whole-body PET/CT scan 40-60 minutes after injection.

Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan
Diagnostic Test: Al18F-NOTA-LM3DRUG

Al18F-NOTA-LM3 will be injected into the patients. Patients will undergo a whole-body PET/CT scan 60-120 minutes after injection.

Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 to 80 years.
  • Suspected or confirmed TIO patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Oncogenic osteomalacia

Central Study Contacts

Hongli Jing

CONTACT

18600586399annsmile1976@sina.com

Yuwei Zhang

CONTACT

18511071577ywzhangwork@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2026

First Posted

January 26, 2026

Study Start

March 30, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

January 26, 2026

Record last verified: 2025-01

Locations

CN(1)