Rectal CancerNCT06318234
PET/MR Evaluation of Regression Grading After Neoadjuvant Therapy for Rectal Cancer
An observational study of Rectal Cancer, run by Xiao Chen at 1 site in China.
Trial summary
This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- 18F-FAPI，18F-FDG
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2025
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects the investigators selected are adults who are not restricted by gender.
Who may be able to join
- Pathologically confirmed as rectal adenocarcinoma, with baseline clinical staging of T3~4 and/or N+;
- No distant metastasis;
- Not receiving chemotherapy or any other anti-tumor treatment before enrollment;
- Has not received immunotherapy before enrollment and is able to adhere to the protocol during the study period (neoadjuvant therapy of short-term radiotherapy sequential chemotherapy combined with immunotherapy);
- After neoadjuvant therapy, 18F-FAPI and 18F-FDG PET/MRI imaging were performed within 7 days before surgery, and the two scans were collected over two days;
- Patient age ≥ 18 years old
Who cannot join
- Pregnant or lactating patients;
- Patients with severe heart disease in clinical practice;
- Organ transplantation requires immunosuppressive therapy and long-term use of hormone therapy;
- Patients with autoimmune diseases;
- Serious uncontrolled recurrent infections or other serious uncontrolled comorbidities;
- The imaging quality is poor and cannot be used for diagnosis and evaluation;
- Fasting blood glucose levels are higher than 11.1 mmol/L;
- Patients with contraindications for MRI examination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing
Xiao Chen, Ph.D, +8615922970174, xiaochen229@foxmail.com
About this study
Official title: Research Focused on Developing and Assessing a Non-intrusive Diagnostic Approach for Grading Tumor Regression Post-neoadjuvant Treatment in Rectal Cancer, Utilizing 18F-FAPI in Conjunction With FDG PET/MR Imaging.
This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed.
Read the detailed description
- Correlation analysis between the expression levels of FAP and GLUT1 and the degree of tumor regression in rectal cancer The study focuses on patients with advanced rectal cancer treated with SCRT neoadjuvant therapy, and conducts immunohistochemical staining of FAP and GLUT1 (glucose transporter 1) on postoperative specimens to evaluate histopathological changes related to the degree of rectal cancer tumor regression. The expression levels of FAP and GLUT1 and the grading of tumor regression are quantitatively analyzed, and their correlation is analyzed to explore the correlation between the expression levels of FAP and GLUT1 in the lesions of neoadjuvant therapy patients and the degree of tumor regression.
- Construction and validation of a diagnostic model for the degree of tumor regression in rectal cancer after neoadjuvant therapy using 18F-FAPI combined with 18F-FDG PET/MRI imaging The patient underwent preoperative 18F-FAPI and 18F-FDG PET/MRI imaging, followed by immunohistochemical staining of FAP and GLUT1 on postoperative specimens and evaluation of histopathological changes related to the degree of rectal cancer tumor regression. The patient's uptake of 18F-FAPI and 18F-FDG (SUVmax, SUVmean, SUVpeak, FAPI metabolic volume, MTV, TBR, TLG), expression levels of FAP and GLUT1, and degree of tumor regression were quantitatively analyzed, and the correlation between the patient's uptake of 18F-FAPI and 18F-FDG and the degree of tumor regression was explored. A graded diagnostic model and evaluation system were constructed to verify their effectiveness.
- Comparison of the efficacy of PET/MR-TRG and MR-TRG in assessing pTRG after neoadjuvant therapy for rectal cancer
Compare the constructed PET/MR tumor regression grading diagnostic model with the commonly used clinical imaging diagnostic method MRI in evaluating the efficacy, pTRG, and pCR of neoadjuvant therapy for rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- 18F-FAPI，18F-FDG
- Keywords
- Rectal cancer, Immunotherapy, New assistance, Efficacy evaluation, 18F-FAPI, 18F-FDG, PET/MRI
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPI，18F-FDGDiagnostic test
FAPI and FDG combined with PET/MR imaging in patients with rectal cancer after neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| After neoadjuvant therapy for rectal cancer | (1) Pathologically confirmed as rectal adenocarcinoma, with baseline clinical staging of T3~4 and/or N+; (2) No distant metastasis; (3) Not receiving chemotherapy or any other anti-tumor treatment before enrollment; (4) Has not received immunotherapy before enrollment and is able to adhere to the protocol during the study period (neoadjuvant therapy of short-term radiotherapy sequential chemotherapy combined with immunotherapy); (5) After neoadjuvant therapy, 18F-FAPI and 18F-FDG PET/MRI imaging were performed within 7 days before surgery, and the two scans were collected over two days; (6) Patient age ≥ 18 years old; (7) The patient voluntarily participates and signs an informed consent form. Receives: Diagnostic Test: 18F-FAPI，18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation efficacy of tumor regression level
The sensitivity, specificity, positive predictive value (PPV), negative predictive value
Measured: Completed within half year after end of the study
Secondary outcomes (3)
expression of FAP
Immunohistochemical evaluation of the expression of FAP in postoperative tumor tissue
Measured: completed within one week after surgery
expression of GLUT1
Immunohistochemical evaluation of the expression of GLUT1 in postoperative tumor tissue
Measured: completed within one week after surgery
SUV
Standardized uptake value (SUV) of 18F-FDG and 18F-FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: Completed within one week after PET examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Xiao Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318234
- Sponsor's protocol ID
- 202435
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Shen L, Wan J, Zhang H, Wu R, Wang J, Wang Y, Xu Y, Cai S, Zhang Z, Xia F. Neoadjuvant chemoradiotherapy combined with immunotherapy for locally advanced rectal cancer: A new era for anal preservation. Front Immunol. 2022 Dec 8;13:1067036. doi: 10.3389/fimmu.2022.1067036. eCollection 2022.
PubMed 36569918
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Focused on Developing and Assessing a Non-intrusive Diagnostic Approach for Grading Tumor Regression Post-neoadjuvant Treatment in Rectal Cancer, Utilizing 18F-FAPI in Conjunction With FDG PET/MR Imaging.
- ClinicalTrials.gov ID
- NCT06318234
- Acronym / sponsor ID
- 202435
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Immunotherapy, New assistance, Efficacy evaluation, 18F-FAPI, 18F-FDG, PET/MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Xiao ChenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Mar 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.
This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed.
Detailed description
- Correlation analysis between the expression levels of FAP and GLUT1 and the degree of tumor regression in rectal cancer The study focuses on patients with advanced rectal cancer treated with SCRT neoadjuvant therapy, and conducts immunohistochemical staining of FAP and GLUT1 (glucose transporter 1) on postoperative specimens to evaluate histopathological changes related to the degree of rectal cancer tumor regression. The expression levels of FAP and GLUT1 and the grading of tumor regression are quantitatively analyzed, and their correlation is analyzed to explore the correlation between the expression levels of FAP and GLUT1 in the lesions of neoadjuvant therapy patients and the degree of tumor regression.
- Construction and validation of a diagnostic model for the degree of tumor regression in rectal cancer after neoadjuvant therapy using 18F-FAPI combined with 18F-FDG PET/MRI imaging The patient underwent preoperative 18F-FAPI and 18F-FDG PET/MRI imaging, followed by immunohistochemical staining of FAP and GLUT1 on postoperative specimens and evaluation of histopathological changes related to the degree of rectal cancer tumor regression. The patient's uptake of 18F-FAPI and 18F-FDG (SUVmax, SUVmean, SUVpeak, FAPI metabolic volume, MTV, TBR, TLG), expression levels of FAP and GLUT1, and degree of tumor regression were quantitatively analyzed, and the correlation between the patient's uptake of 18F-FAPI and 18F-FDG and the degree of tumor regression was explored. A graded diagnostic model and evaluation system were constructed to verify their effectiveness.
- Comparison of the efficacy of PET/MR-TRG and MR-TRG in assessing pTRG after neoadjuvant therapy for rectal cancer
Compare the constructed PET/MR tumor regression grading diagnostic model with the commonly used clinical imaging diagnostic method MRI in evaluating the efficacy, pTRG, and pCR of neoadjuvant therapy for rectal cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| After neoadjuvant therapy for rectal cancer | – | Diagnostic Test: 18F-FAPI，18F-FDG(1) Pathologically confirmed as rectal adenocarcinoma, with baseline clinical staging of T3~4 and/or N+; (2) No distant metastasis; (3) Not receiving chemotherapy or any other anti-tumor treatment before enrollment; (4) Has not received immunotherapy before enrollment and is able to adhere to the protocol during the study period (neoadjuvant therapy of short-term radiotherapy sequential chemotherapy combined with immunotherapy); (5) After neoadjuvant therapy, 18F-FAPI and 18F-FDG PET/MRI imaging were performed within 7 days before surgery, and the two scans were collected over two days; (6) Patient age ≥ 18 years old; (7) The patient voluntarily participates and signs an informed consent form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects the investigators selected are adults who are not restricted by gender.
Key inclusion criteria (6 listed)
- Pathologically confirmed as rectal adenocarcinoma, with baseline clinical staging of T3~4 and/or N+;
- No distant metastasis;
- Not receiving chemotherapy or any other anti-tumor treatment before enrollment;
- Has not received immunotherapy before enrollment and is able to adhere to the protocol during the study period (neoadjuvant therapy of short-term radiotherapy sequential chemotherapy combined with immunotherapy);
- After neoadjuvant therapy, 18F-FAPI and 18F-FDG PET/MRI imaging were performed within 7 days before surgery, and the two scans were collected over two days;
Key exclusion criteria (8 listed)
- Pregnant or lactating patients;
- Patients with severe heart disease in clinical practice;
- Organ transplantation requires immunosuppressive therapy and long-term use of hormone therapy;
- Patients with autoimmune diseases;
- Serious uncontrolled recurrent infections or other serious uncontrolled comorbidities;
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 |
|---|---|---|
| 18F-FAPI，18F-FDGFAPI and FDG combined with PET/MR imaging in patients with rectal cancer after neoadjuvant therapy | Diagnostic test | After neoadjuvant therapy for rectal cancer |
Primary outcome
Evaluation efficacy of tumor regression level
Time frame: Completed within half year after end of the study
The sensitivity, specificity, positive predictive value (PPV), negative predictive value
3 secondary outcomes
expression of FAP
Time frame: completed within one week after surgery
expression of GLUT1
Time frame: completed within one week after surgery
SUV
Time frame: Completed within one week after PET examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Background: PubMed 36569918Wang Y, Shen L, Wan J, Zhang H, Wu R, Wang J, Wang Y, Xu Y, Cai S, Zhang Z, Xia F. Neoadjuvant chemoradiotherapy combined with immunotherapy for locally advanced rectal cancer: A new era for anal preservation. Front Immunol. 2022 Dec 8;13:1067036. doi: 10.3389/fimmu.2022.1067036. eCollection 2022.
- 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 Rectal Cancer, run by Xiao Chen 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 6 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 19 Mar 2024. 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 Xiao Chen, Ph.D (+8615922970174, xiaochen229@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation efficacy of tumor regression level (time frame: Completed within half year after end of the study). 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 NCT06318234, which also lists 1 linked publication.
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 19 Mar 2024.