Esophageal Squamous Cell CarcinomaNCT05287880
Quantitative Analysis of 18F-FAPI Dynamic PET/CT for Accurate Differential Diagnosis of MLN of ESCC
An observational study of Esophageal Squamous Cell Carcinoma and Benign Lymph Node Neoplasm, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
Trial summary
Patients diagnosed with esophageal squamous cell carcinoma based on clinicopathology, laboratory examination and imaging criteria were selected as the research subjects, and compared with conventional 18F-FDG PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma, Benign Lymph Node Neoplasm, Malignant Lymph Node Neoplasm
- What is being tested?
- Dynamic PET/CT
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Mar 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: More than 18 years old and less than 85 years old, no gender limitation, first diagnosis of Esophageal squamous cell carcinoma patients. Patients who must comply with all the inclusion criteria are eligible to participate in this study. However,patients who meet any of the exclusion criteria will not be eligible to participate in this study.
Who may be able to join
- Esophageal squamous cell carcinoma was diagnosed according to gastroscopy and pathological diagnostic criteria;
- Age above 18 years old, less than 85 years old, no gender restriction;
- Untreated patients who have not received surgery, chemotherapy, biotherapy or radiotherapy;
- Laboratory examination:
- General physical condition score ECOG: 0-2; (2) No dysfunction of main organs; (3) Oxygen partial pressure ≥ 10.64kPa; (4) WBC ≥ 4×109 L-1; (5) Routine blood hemoglobin ≥ 9.5 g· DL-1; (6) The absolute count of neutrophils ≥ 1.5×109 L-1; (7) Platelet count ≥ 100×109 L-1; (8) Total bilirubin ≤ 1.5 times the upper limit of normal value; (9) Creatinine ≤ 1.25 times the upper limit of normal value; (10) Creatinine clearance rate ≥ 60 mL ·min-1;
- 5. Can obtain complete follow-up information, understand the situation of this study and sign the informed consent.
Who cannot join
- Has had any other malignant tumor within 5 years;
- Nursing and/or pregnant women;
- Patients with severe bleeding tendency;
- Recent severe hemoptysis, severe cough, dyspnea or patients cannot cooperate;
- Severe emphysema, pulmonary congestion and cor pulmonale;
- In the opinion of the Investigator, the subject may not be able to complete the study or comply with the requirements of the study (for administrative or other reasons).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Quantitative Analysis of 18F-FAPI Dynamic PET/CT for Accurate Differential Diagnosis of Metastatic Lymph Nodes of Esophageal Squamous Cell Carcinoma
Patients diagnosed with esophageal squamous cell carcinoma based on clinicopathology, laboratory examination and imaging criteria were selected as the research subjects, and compared with conventional 18F-FDG PET/CT. To evaluate the research value of quantitative analysis of 18F-FAPI PET/CT dynamic imaging in the classification of benign and malignant features of primary esophageal squamous cell carcinoma (ESCC) and lymphatic nodules, lesion localization, outcome and prognosis.
Read the detailed description
Esophageal cancer (EC) is the eighth most common cancer in the world. Like most other cancers, the occurrence and progression of ESCC is a multi-stage process that closely affects the treatment approach such as endoscopic therapy, surgery, radiotherapy or chemotherapy, and the location of the lesion also affects whether the patient is suitable for surgical resection.Accurate preoperative assessment of lymph node metastasis, disease progression and lesion location is of great significance for early diagnosis and determination of neoadjuvant therapy.
FAP is highly expressed in activated mesenchymal fibroblasts and pericytes in 90% of common human epithelial tumors, as well as in lesions characterized by activation of mesenchymal tissues.The expression of FAP promotes the development of tumors, so inhibiting FAP can slow down the growth of tumors.Currently, several small molecule FAP inhibitors have been functionalized for imaging studies.Studies have shown high uptake of FAPI in sarcoma, esophageal cancer, breast cancer, bile duct cancer, and lung cancer.
Dynamic PET/CT imaging technology with high sensitivity and specificity introduces time parameters while using the fusion technology of PET and CT, providing accurate anatomical positioning in the four-dimensional space and reflecting detailed functional information at molecular level such as functional and metabolic levels.Accurate diagnosis of metastatic lymph nodes of esophageal squamous cell carcinoma can be realized by exploring the kinetic process of various positron probes from entering the body to non-specific distribution and specific distribution.
- Conditions
- Esophageal Squamous Cell Carcinoma, Benign Lymph Node Neoplasm, Malignant Lymph Node Neoplasm
- Being tested
- Dynamic PET/CT
- Keywords
- ESCC, BLN, MLN, Dynamic PET/CT, 18F-FAPI
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic PET/CTDiagnostic test
After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan.
Dynamic PET/CTDiagnostic test
After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan.
| Study group | Role | What they receive |
|---|---|---|
| Non-N0 stage | Patients with malignant lymph nodes. Receives: Diagnostic Test: Dynamic PET/CT | |
| N0 stage | Patients without malignant lymph nodes. Receives: Diagnostic Test: Dynamic PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of SUVmax between MLN and BLN.
Comparison of SUVmax between MLN and BLN.
Measured: 50 min to 60 min
Comparison of K1 between MLN and BLN.
Comparison of K1 of 2TM between MLN and BLN.
Measured: 0 min to 60 min
Comparison of k2 between MLN and BLN.
Comparison of k2 of 2TM between MLN and BLN.
Measured: 0 min to 60 min
Comparison of k3 between MLN and BLN.
Comparison of k3 of 2TM between MLN and BLN.
Measured: 0 min to 60 min
Comparison of k4 between MLN and BLN.
Comparison of k4 of 2TM between MLN and BLN.
Measured: 0 min to 60 min
Comparison of BP between MLN and BLN.
Comparison of BP of LoganREF between MLN and BLN.
Measured: 30 min to 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start10 Mar 2022 (estimated)
- 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.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287880
- Sponsor's protocol ID
- ZDWY.FZYX.009
- Status last verified
- Jun 2021
- First submitted
- 10 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Analysis of 18F-FAPI Dynamic PET/CT for Accurate Differential Diagnosis of Metastatic Lymph Nodes of Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05287880
- Acronym / sponsor ID
- ZDWY.FZYX.009
- Conditions
- Esophageal Squamous Cell Carcinoma, Benign Lymph Node Neoplasm, Malignant Lymph Node Neoplasm
- Keywords
- ESCC, BLN, MLN, Dynamic PET/CT, 18F-FAPI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 10 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 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 diagnosed with esophageal squamous cell carcinoma based on clinicopathology, laboratory examination and imaging criteria were selected as the research subjects, and compared with conventional 18F-FDG PET/CT. To evaluate the research value of quantitative analysis of 18F-FAPI PET/CT dynamic imaging in the classification of benign and malignant features of primary esophageal squamous cell carcinoma (ESCC) and lymphatic nodules, lesion localization, outcome and prognosis.
Detailed description
Esophageal cancer (EC) is the eighth most common cancer in the world. Like most other cancers, the occurrence and progression of ESCC is a multi-stage process that closely affects the treatment approach such as endoscopic therapy, surgery, radiotherapy or chemotherapy, and the location of the lesion also affects whether the patient is suitable for surgical resection.Accurate preoperative assessment of lymph node metastasis, disease progression and lesion location is of great significance for early diagnosis and determination of neoadjuvant therapy.
FAP is highly expressed in activated mesenchymal fibroblasts and pericytes in 90% of common human epithelial tumors, as well as in lesions characterized by activation of mesenchymal tissues.The expression of FAP promotes the development of tumors, so inhibiting FAP can slow down the growth of tumors.Currently, several small molecule FAP inhibitors have been functionalized for imaging studies.Studies have shown high uptake of FAPI in sarcoma, esophageal cancer, breast cancer, bile duct cancer, and lung cancer.
Dynamic PET/CT imaging technology with high sensitivity and specificity introduces time parameters while using the fusion technology of PET and CT, providing accurate anatomical positioning in the four-dimensional space and reflecting detailed functional information at molecular level such as functional and metabolic levels.Accurate diagnosis of metastatic lymph nodes of esophageal squamous cell carcinoma can be realized by exploring the kinetic process of various positron probes from entering the body to non-specific distribution and specific distribution.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-N0 stage | – | Diagnostic Test: Dynamic PET/CTPatients with malignant lymph nodes. |
| N0 stage | – | Diagnostic Test: Dynamic PET/CTPatients without malignant lymph nodes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- More than 18 years old and less than 85 years old, no gender limitation, first diagnosis of Esophageal squamous cell carcinoma patients. Patients who must comply with all the inclusion criteria are eligible to participate in this study. However,patients who meet any of the exclusion criteria will not be eligible to participate in this study.
Key inclusion criteria (6 listed)
- Esophageal squamous cell carcinoma was diagnosed according to gastroscopy and pathological diagnostic criteria;
- Age above 18 years old, less than 85 years old, no gender restriction;
- Untreated patients who have not received surgery, chemotherapy, biotherapy or radiotherapy;
- Laboratory examination:
- General physical condition score ECOG: 0-2; (2) No dysfunction of main organs; (3) Oxygen partial pressure ≥ 10.64kPa; (4) WBC ≥ 4×109 L-1; (5) Routine blood hemoglobin ≥ 9.5 g· DL-1; (6) The absolute count of neutrophils ≥ 1.5×109 L-1; (7) Platelet count ≥ 100×109 L-1; (8) Total bilirubin ≤ 1.5 times the upper limit of normal value; (9) Creatinine ≤ 1.25 times the upper limit of normal value; (10) Creatinine clearance rate ≥ 60 mL ·min-1;
Key exclusion criteria (6 listed)
- Has had any other malignant tumor within 5 years;
- Nursing and/or pregnant women;
- Patients with severe bleeding tendency;
- Recent severe hemoptysis, severe cough, dyspnea or patients cannot cooperate;
- Severe emphysema, pulmonary congestion and cor pulmonale;
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 |
|---|---|---|
| Dynamic PET/CTAfter transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan. | Diagnostic test | Non-N0 stage |
| Dynamic PET/CTAfter transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FAPI intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained. And then underwent whole body static PET scan. | Diagnostic test | N0 stage |
Primary outcome
Comparison of SUVmax between MLN and BLN.
Time frame: 50 min to 60 min
Comparison of SUVmax between MLN and BLN.
Comparison of K1 between MLN and BLN.
Time frame: 0 min to 60 min
Comparison of K1 of 2TM between MLN and BLN.
Comparison of k2 between MLN and BLN.
Time frame: 0 min to 60 min
Comparison of k2 of 2TM between MLN and BLN.
Comparison of k3 between MLN and BLN.
Time frame: 0 min to 60 min
Comparison of k3 of 2TM between MLN and BLN.
Comparison of k4 between MLN and BLN.
Time frame: 0 min to 60 min
Comparison of k4 of 2TM between MLN and BLN.
Comparison of BP between MLN and BLN.
Time frame: 30 min to 60 min
Comparison of BP of LoganREF between MLN and BLN.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Squamous Cell Carcinoma and Benign Lymph Node Neoplasm, run by Fifth Affiliated Hospital, Sun Yat-Sen University.
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 6 inclusion and 6 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 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Hongjun Jin (0756-2526572, jinhj3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of SUVmax between MLN and BLN. (time frame: 50 min to 60 min). The study lists 6 primary outcomes in all. 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 18 Mar 2022.