Head and Neck TumorNCT06438705
99mTc Labeled FAP Targeted Molecular Probe in Early Diagnosis of Tumors
An observational study of Head and Neck Tumor and Lung Cancer, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
At present, radiopharmaceuticals targeting FAP have been developed for the diagnosis and treatment of various tumors. Considering the problems of fast tumor tissue clearance and short retention time in small molecule FAP inhibitors based on quinoline rings, this project optimized their ligands and developed a new FAP… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Tumor, Lung Cancer, Pancreatic Cancer
- What is being tested?
- SPECT-CT imaging
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was mainly conducted by SPECT CT imaging, and a total of 20 cases were planned to be enrolled, which were evaluated by 2 attending physicians of nuclear medicine or above according to various measurement data of the subjects
Who may be able to join
- Voluntary subjects, patients or their legal representatives sign informed consent;
- Volunteers are of any gender and aged between 18 and 75 years old, including the cut-off value;
- Other imaging methods found tumor occupying;
- Patients with pre-treatment tumors for whom surgery or biopsy may be performed to obtain final pathological results.
- Kidney glomerular filtration rate(GFR)>50 ml/min, effective renal plasma flow(ERPF)>280 ml/min, platelet count (PLT) >75 000/μL, white blood cell (WBC) >3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST less than 3 times the normal value.
Who cannot join
- People who have a history of allergy to similar drugs , allergic constitution or are currently suffering from allergic diseases;
- Is conducting clinical research on other drugs, or has participated in clinical research on any drugs (excluding vitamins and minerals);
- Have other clinical problems that are difficult to control (such as hepatitis C virus infection or active hepatitis B, or other serious chronic infections and serious mental, neurological, cardiovascular, respiratory and other diseases);
- Obvious abnormal liver and kidney function, GFR less than 50 ml/min;
- Tumor load is greater than 50%, or there is obvious spinal cord compression;
- The expected survival period is less than half a year; Chemotherapy was performed within 6 months.
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- Have severe acute concomitant diseases or serious refractory mental disorders;
- Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy study);
- Patients whose physical condition is not suitable for radiological examination;
- Other situations deemed inappropriate by the investigator to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Feng Wang, Ph.D., 86-025-52271455, fengwangcn@hotmail.com
About this study
Official title: Clinical Application of a Novel 99mTc Labeled Fibroblast Activating Protein (FAP) Targeted Molecular Probe in Early Diagnosis of Tumors
At present, radiopharmaceuticals targeting FAP have been developed for the diagnosis and treatment of various tumors. Considering the problems of fast tumor tissue clearance and short retention time in small molecule FAP inhibitors based on quinoline rings, this project optimized their ligands and developed a new FAP targeted technetium labeled molecular imaging probe for SPECT/CT imaging research to evaluate its safety in clinical application and its effectiveness in tumor diagnosis.
- Conditions
- Head and Neck Tumor, Lung Cancer, Pancreatic Cancer
- Being tested
- SPECT-CT imaging
- Medical subject headings
- Head and Neck Neoplasms, Lung Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT-CT imagingDiagnostic test
The subjects were intravenously injected with 99mTc labeled FAPI imaging agent, and drank 300-500ml of water after administration. SPECT-CT imaging was performed 60 minutes later
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor uptake
Compare the lesion site with surrounding normal tissue to evaluate whether there is a significant increase in radioactive uptake. Select the lesion in the abnormal area of the image and draw a 3D area of interest (ROI) to obtain the average lesion volume count (T). Calculate the tumor target/non target value (T/NT) statistically
Measured: 1 hour after administering the probe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start1 Jun 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck TumorStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438705
- Sponsor's protocol ID
- KY20240419-08
- Status last verified
- May 2024
- First submitted
- 7 May 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of a Novel 99mTc Labeled Fibroblast Activating Protein (FAP) Targeted Molecular Probe in Early Diagnosis of Tumors
- ClinicalTrials.gov ID
- NCT06438705
- Acronym / sponsor ID
- KY20240419-08
- Conditions
- Head and Neck Tumor, Lung Cancer, Pancreatic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 3 Jun 2024 (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.
At present, radiopharmaceuticals targeting FAP have been developed for the diagnosis and treatment of various tumors. Considering the problems of fast tumor tissue clearance and short retention time in small molecule FAP inhibitors based on quinoline rings, this project optimized their ligands and developed a new FAP targeted technetium labeled molecular imaging probe for SPECT/CT imaging research to evaluate its safety in clinical application and its effectiveness in tumor diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was mainly conducted by SPECT CT imaging, and a total of 20 cases were planned to be enrolled, which were evaluated by 2 attending physicians of nuclear medicine or above according to various measurement data of the subjects
Key inclusion criteria (5 listed)
- Voluntary subjects, patients or their legal representatives sign informed consent;
- Volunteers are of any gender and aged between 18 and 75 years old, including the cut-off value;
- Other imaging methods found tumor occupying;
- Patients with pre-treatment tumors for whom surgery or biopsy may be performed to obtain final pathological results.
- Kidney glomerular filtration rate(GFR)>50 ml/min, effective renal plasma flow(ERPF)>280 ml/min, platelet count (PLT) >75 000/μL, white blood cell (WBC) >3000/μL, alanine aminotransferase ALT, aspartate aminotransferase AST less than 3 times the normal value.
Key exclusion criteria (10 listed)
- People who have a history of allergy to similar drugs , allergic constitution or are currently suffering from allergic diseases;
- Is conducting clinical research on other drugs, or has participated in clinical research on any drugs (excluding vitamins and minerals);
- Have other clinical problems that are difficult to control (such as hepatitis C virus infection or active hepatitis B, or other serious chronic infections and serious mental, neurological, cardiovascular, respiratory and other diseases);
- Obvious abnormal liver and kidney function, GFR less than 50 ml/min;
- Tumor load is greater than 50%, or there is obvious spinal cord compression;
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 |
|---|---|---|
| SPECT-CT imagingThe subjects were intravenously injected with 99mTc labeled FAPI imaging agent, and drank 300-500ml of water after administration. SPECT-CT imaging was performed 60 minutes later | Diagnostic test | – |
Primary outcome
Tumor uptake
Time frame: 1 hour after administering the probe
Compare the lesion site with surrounding normal tissue to evaluate whether there is a significant increase in radioactive uptake. Select the lesion in the abnormal area of the image and draw a 3D area of interest (ROI) to obtain the average lesion volume count (T). Calculate the tumor target/non target value (T/NT) statistically
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Head and Neck Tumor and Lung Cancer, run by Nanjing First Hospital, Nanjing Medical University 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 11 Mar 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor uptake (time frame: 1 hour after administering the probe). 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 11 Mar 2025.