To hear about similar clinical trials, please enter your email below
Trial Title:
68Ga-FAPI-04 PET Imaging in Early Response Evaluation of Rectal Cancer Patients Treated With Immunotherapy
NCT ID:
NCT05999227
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-FAPI-04
Description:
A fibroblast activation protein (FAP) -targeted PET imaging agent
Arm group label:
Immunotherapy
Other name:
68Ga-FAPI
Intervention type:
Drug
Intervention name:
18F-FDG
Description:
A general glucose metabolism imaging agent
Arm group label:
Immunotherapy
Other name:
18F-fluorodeoxyglucose
Summary:
This study is a prospective monocentric study aimed to explore the value of 68Ga-FAPI-04
PET imaging in 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. The general information, clinical data, mpMRI data, 68Ga-FAPI-04 and
18F-FDG PET imaging results and other imaging data of the patients will be collected. The
histopathology of the biopsy or surgical specimen after 2 cycles of therapy and follow-up
data will be taken as evaluation references. This study plans to set the sample size as
20 cases
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
China, Hubei Province
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoli Lan, PhD
Phone:
+86-027-83692633
Email:
lxl730724@hotmail.com
Start date:
June 20, 2023
Completion date:
July 31, 2024
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999227
