Malignant Tumors With Positive NTSR1 ExpressionNCT06977945
Clinical Application of FL-091 Radionuclide Imaging in Diagnosis and Staging of Malignant Tumors
An observational study of Malignant Tumors With Positive NTSR1 Expression, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Malignant tumors pose a serious threat to human health, and early diagnosis and early treatment are crucial to improving the patient's prognosis. Nuclear medicine imaging technology injects radioisotope labeled molecules (such as monoclonal antibodies and peptides) into the body to identify and bind specific targets… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumors With Positive NTSR1 Expression
- What is being tested?
- Specific positron imaging agents targeting NTRS-1(FL-091)
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically suspected or confirmed malignant tumors such as head and neck cancer, colorectal cancer, or pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition.
Who may be able to join
- Each subject must meet all enrollment criteria to be eligible to participate in the study:
- The subject or his/her legal representative is able to sign and date the informed consent form;
- A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
- Adult patients or healthy volunteers (aged 18 or above) of either sex;
- Patients with clinically suspected or confirmed malignant tumors such as head and neck cancer, colorectal cancer, or pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
- Consistent with the results of specific laboratory tests;
- Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study；
- Other set entry criteria.
Who cannot join
- All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
- Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
- Having other comorbidities;
- Patients with known hypersensitivity to FL-091 fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
- Have a history of comorbid drug use;
- Patients considered by the investigator to have poor compliance;
- Patients during pregnancy or lactation;
- Persons with other factors that make participation in this test inappropriate.
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
Wuhan Union Hospital,China
Wuhan, Hubei, 430030
Xiaoli Lan, PhD, +86-027-83692633, lxl730724@hotmail.com
Xiaoli Lan, PhD
About this study
Malignant tumors pose a serious threat to human health, and early diagnosis and early treatment are crucial to improving the patient's prognosis. Nuclear medicine imaging technology injects radioisotope labeled molecules (such as monoclonal antibodies and peptides) into the body to identify and bind specific targets of different tumor cells, thereby achieving accurate early diagnosis of different tumors. Neurotensin receptor 1 (NTSR1) is overexpressed in many malignant tumors such as colon cancer, pancreatic cancer, gastric cancer, head and neck cancer, and is closely related to tumor occurrence, development and prognosis. At the same time, NTSR1 is low expressed in surrounding normal tissues, so NTSR1 is an excellent target for the diagnosis and diagnosis of the above-mentioned series of malignant tumors. Probes targeting NTSR1 have been gradually explored. FL-091 is a new NTSR1-targeted radionuclide conjugated drug (RDC) that has high affinity and specificity for NTSR1 in previous preclinical studies. Compared with conventional NTSR1 inhibitors, FL-091 has the following potential advantages: ① Potential for radiotherapy: FL-091 can combine with radioactive isotopes such as 177Lu or 225Ac to directly deliver radioactive energy to tumor cells. This radiation therapy can produce cytotoxicity in a local area, killing tumor cells while causing less damage to surrounding healthy tissues;② Selectivity and specificity: Since FL-091 is designed based on the high affinity of NTSR1, it can more selectively target tumor cells that express NTSR1. This high degree of specificity can reduce the impact on normal cells and increase the accuracy of imaging and treatment.③ Biodistribution and rapid clearance: FL-091 demonstrated optimized biodistribution characteristics, such as higher tumor uptake rates and faster clearance of normal tissues. This means it can effectively deliver radioactive material to tumor tissue while reducing radiation exposure to healthy tissue. Based on the above advantages, FL-091 labeled with imaging nuclide or therapeutic nuclide is expected to be used for precise imaging and treatment of targeted NTSR1, bringing new diagnosis and treatment methods to patients.
In this project, it is planned to use 68Ga and 111In to label FL-091 respectively for PET or SPECT imaging to initially evaluate the biodistribution of the probe in the human body, and diagnose and stage various malignant tumors including head and neck cancer, colorectal cancer and pancreatic adenocarcinoma. We will discuss the detection performance of 68Ga-FL-091 and 111In-FL-091 on malignant tumors, and lay the foundation for future use of therapeutic nuclide labeled FL-091 for nuclide targeted internal irradiation treatment of malignant tumors.
- Being tested
- Specific positron imaging agents targeting NTRS-1(FL-091)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific positron imaging agents targeting NTRS-1(FL-091)Diagnostic test
This study is diagnostic. Oncologists screen patients with malignant tumors such as head and neck cancer, colorectal cancer, and pancreatic adenocarcinoma who are clinically suspected or confirmed; investigators talk to patients who meet the inclusion criteria, explain the study purpose and study process, sign informed consent forms, and patients can complete 68Ga-FL-091PET imaging and 111In-FL-091SPECT imaging respectively in outpatient or inpatient periods. General information, clinical data, blood routine, urine routine, liver and kidney function and other biochemical indicators, electrocardiogram, radionuclide imaging results and other imaging data of the patients participating in the study were collected and compared with histopathology to evaluate the value of both imaging in the diagnosis of head and neck cancer, colorectal cancer, and pancreatic adenocarcinoma.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Diagnostic Test: Specific positron imaging agents targeting NTRS-1(FL-091) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual and standardized uptake values assessment of lesions and biodistribution
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting NTSR-1 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.
Measured: 1 year
Secondary outcomes (1)
Pathological sections of tumour tissue
The excised tumour tissue was taken for immunohistochemistry to verify its NTSR-1 expression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start25 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Tumors With Positive NTSR1 ExpressionStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977945
- Sponsor's protocol ID
- XLan-0505
- Status last verified
- Jan 2026
- First submitted
- 9 May 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of FL-091 Radionuclide Imaging in Diagnosis and Staging of Malignant Tumors
- ClinicalTrials.gov ID
- NCT06977945
- Acronym / sponsor ID
- XLan-0505
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 May 2025 (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.
Malignant tumors pose a serious threat to human health, and early diagnosis and early treatment are crucial to improving the patient's prognosis. Nuclear medicine imaging technology injects radioisotope labeled molecules (such as monoclonal antibodies and peptides) into the body to identify and bind specific targets of different tumor cells, thereby achieving accurate early diagnosis of different tumors. Neurotensin receptor 1 (NTSR1) is overexpressed in many malignant tumors such as colon cancer, pancreatic cancer, gastric cancer, head and neck cancer, and is closely related to tumor occurrence, development and prognosis. At the same time, NTSR1 is low expressed in surrounding normal tissues, so NTSR1 is an excellent target for the diagnosis and diagnosis of the above-mentioned series of malignant tumors. Probes targeting NTSR1 have been gradually explored. FL-091 is a new NTSR1-targeted radionuclide conjugated drug (RDC) that has high affinity and specificity for NTSR1 in previous preclinical studies. Compared with conventional NTSR1 inhibitors, FL-091 has the following potential advantages: ① Potential for radiotherapy: FL-091 can combine with radioactive isotopes such as 177Lu or 225Ac to directly deliver radioactive energy to tumor cells. This radiation therapy can produce cytotoxicity in a local area, killing tumor cells while causing less damage to surrounding healthy tissues;② Selectivity and specificity: Since FL-091 is designed based on the high affinity of NTSR1, it can more selectively target tumor cells that express NTSR1. This high degree of specificity can reduce the impact on normal cells and increase the accuracy of imaging and treatment.③ Biodistribution and rapid clearance: FL-091 demonstrated optimized biodistribution characteristics, such as higher tumor uptake rates and faster clearance of normal tissues. This means it can effectively deliver radioactive material to tumor tissue while reducing radiation exposure to healthy tissue. Based on the above advantages, FL-091 labeled with imaging nuclide or therapeutic nuclide is expected to be used for precise imaging and treatment of targeted NTSR1, bringing new diagnosis and treatment methods to patients.
In this project, it is planned to use 68Ga and 111In to label FL-091 respectively for PET or SPECT imaging to initially evaluate the biodistribution of the probe in the human body, and diagnose and stage various malignant tumors including head and neck cancer, colorectal cancer and pancreatic adenocarcinoma. We will discuss the detection performance of 68Ga-FL-091 and 111In-FL-091 on malignant tumors, and lay the foundation for future use of therapeutic nuclide labeled FL-091 for nuclide targeted internal irradiation treatment of malignant tumors.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Specific positron imaging agents targeting NTRS-1(FL-091) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically suspected or confirmed malignant tumors such as head and neck cancer, colorectal cancer, or pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition.
Key inclusion criteria (8 listed)
- Each subject must meet all enrollment criteria to be eligible to participate in the study:
- The subject or his/her legal representative is able to sign and date the informed consent form;
- A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
- Adult patients or healthy volunteers (aged 18 or above) of either sex;
- Patients with clinically suspected or confirmed malignant tumors such as head and neck cancer, colorectal cancer, or pancreatic cancer (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
Key exclusion criteria (8 listed)
- All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
- Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
- Having other comorbidities;
- Patients with known hypersensitivity to FL-091 fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
- Have a history of comorbid drug use;
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 |
|---|---|---|
| Specific positron imaging agents targeting NTRS-1(FL-091)This study is diagnostic. Oncologists screen patients with malignant tumors such as head and neck cancer, colorectal cancer, and pancreatic adenocarcinoma who are clinically suspected or confirmed; investigators talk to patients who meet the inclusion criteria, explain the study purpose and study process, sign informed consent forms, and patients can complete 68Ga-FL-091PET imaging and 111In-FL-091SPECT imaging respectively in outpatient or inpatient periods. General information, clinical data, blood routine, urine routine, liver and kidney function and other biochemical indicators, electrocardiogram, radionuclide imaging results and other imaging data of the patients participating in the study were collected and compared with histopathology to evaluate the value of both imaging in the diagnosis of head and neck cancer, colorectal cancer, and pancreatic adenocarcinoma. | Diagnostic test | 1 |
Primary outcome
Visual and standardized uptake values assessment of lesions and biodistribution
Time frame: 1 year
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting NTSR-1 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.
1 secondary outcome
Pathological sections of tumour tissue
Time frame: 1 year
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 13 Jan 2026.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Malignant Tumors With Positive NTSR1 Expression, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 8 inclusion and 8 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 13 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 Xiaoli Lan, PhD (0086-027-83692633, lxl730724@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual and standardized uptake values assessment of lesions and biodistribution (time frame: 1 year). 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 13 Jan 2026.