Gastrointestinal CancerNCT05420558
Fibroblast Activation Protein Inhibitor PET/CT Imaging in Malignant Tumor of Digestive System
An observational study of Gastrointestinal Cancer, run by Zhongnan Hospital at 1 site in China.
Trial summary
The purpose of this single center prospective study is to assess the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Fibroblast activation protein inhibitor PET/CT imaging
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2022to 31 Dec 2023
- 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 suspected or new diagnosed gastrointestinal cancer or other malignant tumor of digestive system.
Who may be able to join
- Voluntarily participate and sign the informed consent.
- Patients with suspected or new diagnosed gastrointestinal cancer or other malignant tumor of digestive system.
- Complete clinical information, biochemical examination results, CT and/or MRI imaging examination, pathological information, and clinical/imaging follow-up data.
Who cannot join
- Female patient who plan to become pregnant within 6 months, or pregnant or breast-feeding women.
- Allergic constitution.
- Those who are in poor general condition and cannot tolerate PET/CT examination.
- The researchers believe that he or she is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Chongjiao Li, +86-27-67812698
About this study
Official title: The Application of Molecular Probe Targeting Fibroblast Activation Protein in Malignant Tumor of Digestive System
The purpose of this single center prospective study is to assess the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions.
Read the detailed description
Malignant tumor of digestive system is one of the most common cancer types worldwide with high cancer-related mortalities. FDG PET/CT is an essential imaging modality in the tumor treatment and management. However, FDG PET/CT has certain limitations. For example, the detection sensitivity and tracer uptake in signet ring cell carcinoma (SRCC) is low. Furthermore, the physiological uptake of the gastrointestinal tract and acute gastroenteritis may mask the detection of lesion in the abdomen and pelvis. Therefore, a novel molecular imaging tracer is needed for the accurate evaluation of malignant tumor of digestive system.
Cancer-associated fibroblasts (CAFs) specifically express fibroblast activation protein (FAP), which is highly expressed by CAFs in more than 90% of human epithelial cancers. FAP-specific small molecule inhibitors (FAPIs) show much advantages over FDG, including high tumor accumulation, low background tissue uptake, and rapid clearance in vivo.
The purpose of this single center prospective study is to assess the value of FAPI PET/CT imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions.
In this study, qualitative and quantitative analyses will be used. The diagnostic criteria of FAPI PET/CT: if the FAPI uptake of lesion is higher than that of the surrounding background tissue, it is determined as a positive lesion; if the FAPI uptake of the lesion is the same as or lower than that of the surrounding background tissue, it is determined as a negative lesion. Pathological result is used as the gold standard for diagnosis. The diagnostic performance of FAPI PET/CT including sensitivity, specificity, positive predictive value, negative predictive value, and accuracy will be calculated.
The quantitative indicators include the following metabolic parameters: maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), tumor metabolic volume (MTV), total tumor glycolysis (TLG), tumor-to-liver ratio, and tumor-to-background tissue ratio.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Fibroblast activation protein inhibitor PET/CT imaging
- Keywords
- fibroblast activation protein inhibitor, positron emission tomography, gastrointestinal cancer, digestive system tumor, recurrence, metastases, prognosis
- Medical subject headings
- Gastrointestinal Neoplasms, Digestive System Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroblast activation protein inhibitor PET/CT imagingDiagnostic test
All participants will receive a 68Ga-labelled fibroblast activation protein inhibitor PET/CT imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative recurrence
Evaluation of the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system
Measured: two years
Secondary outcomes (1)
diagnostic performance
Evaluation of the diagnostic performance of FAPI PET imaging in detecting malignant tumor of digestive system
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start23 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal CancerStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chongjiao Li, MD, PhD, Study director, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420558
- Sponsor's protocol ID
- ZNYYPTXM2022013
- Status last verified
- Jul 2023
- First submitted
- 10 Jun 2022
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared with other researchers. Our research results will eventually be shared with other researchers in the form of paper.
Publications
Lin R, Lin Z, Chen Z, Zheng S, Zhang J, Zang J, Miao W. [68Ga]Ga-DOTA-FAPI-04 PET/CT in the evaluation of gastric cancer: comparison with [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2960-2971. doi: 10.1007/s00259-022-05799-5. Epub 2022 Apr 25.
PubMed 35462566Fu L, Huang S, Wu H, Dong Y, Xie F, Wu R, Zhou K, Tang G, Zhou W. Superiority of [68Ga]Ga-FAPI-04/[18F]FAPI-42 PET/CT to [18F]FDG PET/CT in delineating the primary tumor and peritoneal metastasis in initial gastric cancer. Eur Radiol. 2022 Sep;32(9):6281-6290. doi: 10.1007/s00330-022-08743-1. Epub 2022 Apr 5.
PubMed 35380229Qin C, Song Y, Gai Y, Ruan W, Liu Q, Liu F, Zheng D, Zhang P, Liu H, Zhang T, Tao K, Lan X. Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4228-4240. doi: 10.1007/s00259-022-05847-0. Epub 2022 Jun 3.
PubMed 35657428
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Molecular Probe Targeting Fibroblast Activation Protein in Malignant Tumor of Digestive System
- ClinicalTrials.gov ID
- NCT05420558
- Acronym / sponsor ID
- ZNYYPTXM2022013
- Conditions
- Gastrointestinal Cancer
- Keywords
- fibroblast activation protein inhibitor, positron emission tomography, gastrointestinal cancer, digestive system tumor, recurrence, metastases, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Jun 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.
The purpose of this single center prospective study is to assess the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions.
Detailed description
Malignant tumor of digestive system is one of the most common cancer types worldwide with high cancer-related mortalities. FDG PET/CT is an essential imaging modality in the tumor treatment and management. However, FDG PET/CT has certain limitations. For example, the detection sensitivity and tracer uptake in signet ring cell carcinoma (SRCC) is low. Furthermore, the physiological uptake of the gastrointestinal tract and acute gastroenteritis may mask the detection of lesion in the abdomen and pelvis. Therefore, a novel molecular imaging tracer is needed for the accurate evaluation of malignant tumor of digestive system.
Cancer-associated fibroblasts (CAFs) specifically express fibroblast activation protein (FAP), which is highly expressed by CAFs in more than 90% of human epithelial cancers. FAP-specific small molecule inhibitors (FAPIs) show much advantages over FDG, including high tumor accumulation, low background tissue uptake, and rapid clearance in vivo.
The purpose of this single center prospective study is to assess the value of FAPI PET/CT imaging in predicting early postoperative recurrence of malignant tumor of digestive system and to evaluate the diagnostic performance of FAPI PET/CT in the detection of primary tumor and metastatic lesions.
In this study, qualitative and quantitative analyses will be used. The diagnostic criteria of FAPI PET/CT: if the FAPI uptake of lesion is higher than that of the surrounding background tissue, it is determined as a positive lesion; if the FAPI uptake of the lesion is the same as or lower than that of the surrounding background tissue, it is determined as a negative lesion. Pathological result is used as the gold standard for diagnosis. The diagnostic performance of FAPI PET/CT including sensitivity, specificity, positive predictive value, negative predictive value, and accuracy will be calculated.
The quantitative indicators include the following metabolic parameters: maximum standard uptake value (SUVmax), mean standard uptake value (SUVmean), tumor metabolic volume (MTV), total tumor glycolysis (TLG), tumor-to-liver ratio, and tumor-to-background tissue ratio.
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 suspected or new diagnosed gastrointestinal cancer or other malignant tumor of digestive system.
Key inclusion criteria (3 listed)
- Voluntarily participate and sign the informed consent.
- Patients with suspected or new diagnosed gastrointestinal cancer or other malignant tumor of digestive system.
- Complete clinical information, biochemical examination results, CT and/or MRI imaging examination, pathological information, and clinical/imaging follow-up data.
Key exclusion criteria (4 listed)
- Female patient who plan to become pregnant within 6 months, or pregnant or breast-feeding women.
- Allergic constitution.
- Those who are in poor general condition and cannot tolerate PET/CT examination.
- The researchers believe that he or she is not suitable to participate in this study.
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 |
|---|---|---|
| Fibroblast activation protein inhibitor PET/CT imagingAll participants will receive a 68Ga-labelled fibroblast activation protein inhibitor PET/CT imaging | Diagnostic test | – |
Primary outcome
early postoperative recurrence
Time frame: two years
Evaluation of the value of FAPI PET imaging in predicting early postoperative recurrence of malignant tumor of digestive system
1 secondary outcome
diagnostic performance
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Background: PubMed 35462566Lin R, Lin Z, Chen Z, Zheng S, Zhang J, Zang J, Miao W. [68Ga]Ga-DOTA-FAPI-04 PET/CT in the evaluation of gastric cancer: comparison with [18F]FDG PET/CT. Eur J Nucl Med Mol Imaging. 2022 Jul;49(8):2960-2971. doi: 10.1007/s00259-022-05799-5. Epub 2022 Apr 25.
- Background: PubMed 35380229Fu L, Huang S, Wu H, Dong Y, Xie F, Wu R, Zhou K, Tang G, Zhou W. Superiority of [68Ga]Ga-FAPI-04/[18F]FAPI-42 PET/CT to [18F]FDG PET/CT in delineating the primary tumor and peritoneal metastasis in initial gastric cancer. Eur Radiol. 2022 Sep;32(9):6281-6290. doi: 10.1007/s00330-022-08743-1. Epub 2022 Apr 5.
- Background: PubMed 35657428Qin C, Song Y, Gai Y, Ruan W, Liu Q, Liu F, Zheng D, Zhang P, Liu H, Zhang T, Tao K, Lan X. Gallium-68-labeled fibroblast activation protein inhibitor PET in gastrointestinal cancer: insights into diagnosis and management. Eur J Nucl Med Mol Imaging. 2022 Oct;49(12):4228-4240. doi: 10.1007/s00259-022-05847-0. Epub 2022 Jun 3.
- Individual participant dataSharing planned: No. The individual participant data will not be shared with other researchers. Our research results will eventually be shared with other researchers in the form of paper.
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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.
Chongjiao Li, MD, PhD study director
Wuhan University
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 Gastrointestinal Cancer, 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 3 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: status not confirmed, as of the sponsor's last update on 17 Jul 2023. 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 Chongjiao Li, MD, PhD (+86-18827093900, LCJ0301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early postoperative recurrence (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05420558, which also lists 3 linked publications.
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 17 Jul 2023.