Tumor-Induced OsteomalaciaNCT07366099
Al18F-NOTA-LM3 PET/CT in Patients With TIO
A study testing Diagnostic Test: Al18F-NOTA-LM3 and Diagnostic Test: 68Ga-DOTATATE in people with Tumor-Induced Osteomalacia, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a pilot study to assess the value of whole-body Al18F-NOTA-LM3 PET/CT in patients with tumor-induced osteomalacia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tumor-Induced Osteomalacia
- What is being tested?
- Diagnostic Test: Al18F-NOTA-LM3 and Diagnostic Test: 68Ga-DOTATATE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2023to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years.
- Suspected or confirmed TIO patients.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Hongli Jing, 18600586399, annsmile1976@sina.com
About this study
Official title: Application of Al18F-NOTA-LM3 PET/CT in the Diagnosis and Evaluation of Tumor-Induced Osteomalacia
This is a pilot study to assess the value of whole-body Al18F-NOTA-LM3 PET/CT in patients with tumor-induced osteomalacia.
Read the 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.
- Conditions
- Tumor-Induced Osteomalacia
- Being tested
- Diagnostic Test: Al18F-NOTA-LM3, Diagnostic Test: 68Ga-DOTATATE
- Medical subject headings
- Oncogenic osteomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Diagnostic Test: Al18F-NOTA-LM3; Drug: Diagnostic Test: 68Ga-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and specificity of Al18F-NOTA-LM3 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT
Measured: From study completion to 6 months after completion.
Secondary outcomes (1)
standardized uptake value (SUV) of tumor
Compare the SUVmax of tumor derived from Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT.
Measured: From study completion to 6 months after completion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start30 Mar 2023
- Primary completion28 Feb 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor-Induced OsteomalaciaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366099
- Sponsor's protocol ID
- ALFLM3TIO
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Al18F-NOTA-LM3 PET/CT in the Diagnosis and Evaluation of Tumor-Induced Osteomalacia
- ClinicalTrials.gov ID
- NCT07366099
- Acronym / sponsor ID
- ALFLM3TIO
- Conditions
- Tumor-Induced Osteomalacia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan | Experimental | Drug: Diagnostic Test: Al18F-NOTA-LM3, Drug: Diagnostic Test: 68Ga-DOTATATEPatients of TIO PET/CT imaging: Patients will perform an Al18F-NOTA-LM3 PET/CT as well as a 68Ga-DOTATATE PET/CT. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 80 years.
- Suspected or confirmed TIO patients.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic Test: Al18F-NOTA-LM3Al18F-NOTA-LM3 will be injected into the patients. Patients will undergo a whole-body PET/CT scan 60-120 minutes after injection. | Drug | Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan |
| Diagnostic Test: 68Ga-DOTATATE68Ga-DOTATATE will be injected into the patients. Patients will undergo a whole-body PET/CT scan 40-60 minutes after injection. | Drug | Al18F-NOTA-LM3 and 68Ga-DOTATATE PET/CT scan |
Primary outcome
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
1 secondary outcome
standardized uptake value (SUV) of tumor
Time frame: From study completion to 6 months after completion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
Related trials for Tumor-Induced Osteomalacia
Active, not recruitingObservational study
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RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: Al18F-NOTA-LM3 and Diagnostic Test: 68Ga-DOTATATE in people with Tumor-Induced Osteomalacia, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongli Jing (18600586399, annsmile1976@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic value (time frame: From study completion to 6 months after completion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.