- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05999227
68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy
68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy: A Single-center Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The response patterns of immune checkpoint inhibitors (ICIs) in solid tumors are diverse and complicated. Pseudoprogression, progression and even hyperprogression can occur. The main mechanism of pseudoprogression is the infiltration of immune cells into the tumor lesion, causing blurred tumor margins and even an increase in the volume of the entire tumor lesion (secondary delayed response). For pseudoprogression, irRC, irRECIST, iRECIST and other immune-related solid tumor efficacy evaluation criteria based on anatomical images are not enough to confirm, and the inflammation caused by T cell infiltration also shows strong uptake of 18F-FDG. The existing criteria for the response evaluation in solid tumors cannot early identify progression or pseudoprogression.
Fibroblast activation protein (FAP) is highly specifically expressed on the membrane surface of carcinoma-associated fibroblast (CAF). FAP-positive CAFs exist in a variety of solid tumors including rectal cancer and are mainly involved in the formation of tumor stroma. However, FAP is rarely expressed in normal tissues. Therefore, 68Ga-FAPI-04 PET, a FAP-targeted imaging modality, can be used to differentiate tumors and normal tissues and has been widely used in clinical studies. Its sensitivity and specificity outperformed 18F-FDG PET. Studies have shown that tumors with high FAP expression are associated with poor response immunotherapy. Although FAP-targeted imaging has been widely used in predicting the response to immune checkpoint inhibitors, it has rarely been reported in rectal cancer.
This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04 PET imaging in the early response evaluation of rectal cancer patients treated with immunotherapy. Patients with histopathologically confirmed diagnosis of rectal cancer will be recruited and undergo 68Ga-FAPI-04 and 18F-FDG PET imaging before treatment and after short-course radiotherapy and two cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart. The efficacy of 68Ga-FAPI-04 in early response evaluation will be compared with the general imaging agent 18F-FDG.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Xiaoli Lan
- Phone Number: 0086-027-83692633
- Email: lxl730724@hotmail.com
Study Locations
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Hubei
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Wuhan, Hubei, China, 430022
- Recruiting
- China, Hubei Province
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Contact:
- Xiaoli Lan, PhD
- Phone Number: +86-027-83692633
- Email: lxl730724@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically confirmed T3-4N0M0 or T1-4N+M0 (according to the 8th edition of the International Union Against Cancer TNM staging system) rectal adenocarcinoma and treatment naïve;
- No severe hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities or immunodeficiency diseases;
- An Eastern Cooperative Oncology Group Performance Status of 0-1;
- Patients who agree to undergo 68Ga-FAPI-04 and 18F-FDG PET imaging.
Exclusion Criteria:
- Any experiences of anti-programmed death ligand 1 (PD-L1) or anti-PD-1 antibody treatment;
- A history of pelvic radiation;
- The presence of autoimmune disease;
- Hypersensitive to any monoclonal antibodies;
- History of interstitial lung disease;
- Active and uncontrolled infection.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immunotherapy
Patients with rectal cancer will receive short-course radiotherapy and neoadjuvant chemotherapy plus immunotherapy. 68Ga-FAPI-04 and 18F-FDG PET will be performed at baseline and after short-course radiotherapy and 2 cycles of neoadjuvant chemotherapy plus immunotherapy. The two imaging intervals will be completed two days apart. |
A fibroblast activation protein (FAP) -targeted PET imaging agent
Other Names:
A general glucose metabolism imaging agent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
68Ga-FAPI-04 PET analysis
Time Frame: Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)
|
PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.
|
Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)
|
18F-FDG PET analysis
Time Frame: Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)
|
PET parameter (SUVmax in g/ml, MTV in cm3, TLG in g/ml×cm3, etc.) changes between both scans will be measured.
|
Baseline and 21-28 days after 2 cycles of neoadjuvant chemotherapy plus immunotherapy (each cycle is 21-28 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Xiaoli Lan, Wuhan Union Hospital, China
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Radiopharmaceuticals
- Fluorodeoxyglucose F18
Other Study ID Numbers
- XLan-0379
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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