Hepatobiliary DiseasesNCT05264688
The Function of PET Molecular Imaging Targeting Fibroblast Activation Protein in the Hepatobiliary Malignancies
An observational study of Hepatobiliary Diseases, run by Zhongnan Hospital at 1 site in China.
Trial summary
Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week, and collect tumor tissue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatobiliary Diseases
- What is being tested?
- 68Ga-FAPI-04 imaging agent
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2022to 31 Oct 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high clinical suspicion of hepatobiliary malignancies and meeting the inclusion and exclusion criteria
Who may be able to join
- Voluntarily participate and sign a written informed consent;
- 18-80 years old (inclusive) male or female;
- Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc.
- Those who obtained pathological diagnosis results through needle biopsy or surgical resection;
- Have willingness and ability to participate in all research procedures.
Who cannot join
- Women who are pregnant or breastfeeding;
- Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients;
- Those who have a history of other malignant tumors in the past;
- Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L;
- Patients with claustrophobia;
- Those who cannot tolerate lying down for 15-30 minutes;
- The researchers believe that it is not suitable to participate in this clinical trial;
- Those who have participated in clinical trials or are participating in other clinical trials within the past month
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital
Wuhan, Hubei, 430000
Yufeng Yuan, yuanyf1971@whu.edu.cn
About this study
Official title: The Role of Novel PET Molecular Imaging Targeting Fibroblast Activation Protein in the Diagnosis of Hepatobiliary Malignancies
Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week, and collect tumor tissue. Finally, the PET/CT results were compared with the pathology report to evaluate the role of 68Ga-FAPI PET/CT imaging in the diagnosis of hepatobiliary malignancies
Read the detailed description
Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week. After comprehensive clinical evaluation, if the patient can be treated with surgery, surgery will be performed, and the patient's pathological specimens will be collected after surgery ; If the patient has no possibility of surgery, ultrasound-guided needle biopsy is performed, and biopsy specimens are collected. Finally, the PET/CT results were compared with the pathology report to evaluate the application value of 68Ga-FAPI PET/CT imaging in the diagnosis and staging of hepatobiliary malignant tumors, and to analyze the guiding significance for the treatment decision of hepatobiliary malignant tumors.
- Conditions
- Hepatobiliary Diseases
- Being tested
- 68Ga-FAPI-04 imaging agent
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-04 imaging agentDiagnostic test
1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg) intravenously
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnose accordance rate
Proportion of PET/CT diagnostic reports consistent with pathological results
Measured: 2022.1.20-2022.7.30
Secondary outcomes (5)
Standardized Uptake Mean (SUVmean)
The average of the standard uptake value
Measured: 2022.1.20-2022.7.30
Standardized Uptake Maximum (SUVmax)
The maximum value of the standard uptake value
Measured: 2022.1.20-2022.7.30
Tumor Background Ratio
The ratio of the radiation concentration in the tumor area to the surrounding background
Measured: 2022.1.20-2022.7.30
Tumor Metabolic Volume (MTV)
The metabolically active volume of tumor tissue
Measured: 2022.1.20-2022.7.30
Total Glycolysis (TLG)
Tumor metabolic volume is multiplied by the mean of standard uptake
Measured: 2022.1.20-2022.7.30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start20 Jan 2022
- Primary completion30 Jul 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary DiseasesStudies of the same condition, open and under way.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yufeng Yuan, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264688
- Sponsor's protocol ID
- 20220207
- Status last verified
- Apr 2022
- First submitted
- 7 Feb 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Novel PET Molecular Imaging Targeting Fibroblast Activation Protein in the Diagnosis of Hepatobiliary Malignancies
- ClinicalTrials.gov ID
- NCT05264688
- Acronym / sponsor ID
- 20220207
- Conditions
- Hepatobiliary Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 3 Mar 2022 (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.
Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week, and collect tumor tissue. Finally, the PET/CT results were compared with the pathology report to evaluate the role of 68Ga-FAPI PET/CT imaging in the diagnosis of hepatobiliary malignancies
Detailed description
Patients with high clinical suspicion of hepatobiliary malignancies should undergo PET/CT examination with two imaging agents, 68Ga-FAPI (fibroblast activation protein inhibitor) and 18F-FDG within one week. After comprehensive clinical evaluation, if the patient can be treated with surgery, surgery will be performed, and the patient's pathological specimens will be collected after surgery ; If the patient has no possibility of surgery, ultrasound-guided needle biopsy is performed, and biopsy specimens are collected. Finally, the PET/CT results were compared with the pathology report to evaluate the application value of 68Ga-FAPI PET/CT imaging in the diagnosis and staging of hepatobiliary malignant tumors, and to analyze the guiding significance for the treatment decision of hepatobiliary malignant tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high clinical suspicion of hepatobiliary malignancies and meeting the inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Voluntarily participate and sign a written informed consent;
- 18-80 years old (inclusive) male or female;
- Patients with high clinical suspicion of hepatobiliary malignancy in combination with medical history and imaging studies, etc.
- Those who obtained pathological diagnosis results through needle biopsy or surgical resection;
- Have willingness and ability to participate in all research procedures.
Key exclusion criteria (8 listed)
- Women who are pregnant or breastfeeding;
- Those who are known to be allergic to the imaging agent 68Ga-FAPI or its excipients;
- Those who have a history of other malignant tumors in the past;
- Before the injection of 18F-FDG, the fasting blood glucose level exceeds 11.0mmol/L;
- Patients with claustrophobia;
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 |
|---|---|---|
| 68Ga-FAPI-04 imaging agent1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg) intravenously | Diagnostic test | – |
Primary outcome
diagnose accordance rate
Time frame: 2022.1.20-2022.7.30
Proportion of PET/CT diagnostic reports consistent with pathological results
5 secondary outcomes
Standardized Uptake Mean (SUVmean)
Time frame: 2022.1.20-2022.7.30
Standardized Uptake Maximum (SUVmax)
Time frame: 2022.1.20-2022.7.30
Tumor Background Ratio
Time frame: 2022.1.20-2022.7.30
Tumor Metabolic Volume (MTV)
Time frame: 2022.1.20-2022.7.30
Total Glycolysis (TLG)
Time frame: 2022.1.20-2022.7.30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatobiliary Diseases
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Recruiting
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
Liver Diseases
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 Hepatobiliary Diseases, run by Zhongnan 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 5 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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?
Contact Yufeng Yuan (13995564795, yuanyf1971@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnose accordance rate (time frame: 2022.1.20-2022.7.30). 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 27 Apr 2022.