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Trial Title:
68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer
NCT ID:
NCT06084767
Condition:
Malignant Tumor
Positron Emission Tomography
Fibroblast Activation Protein Inhibitor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Malignant Tumor
Positron Emission Tomography
Fibroblast Activation Protein Inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
68Ga-TCR-FAPI PET/CT was used for patients with suspected malignant tumors
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-TCR-FAPI PET/CT
Description:
A dose of 3.7 MBq/kg 68Ga-TCR-FAPI will be intravenously injected and PET examination
will be carried out within the specified time.
Arm group label:
Malignant tumors
Summary:
Adding targeted covalent radiopharmaceutical (TCR) moiety to fibroblast activation
protein inhibitor (FAPI) can increase tumor uptake and tumor retention in pre-clinical
studies. This study is an open-labeled single-arm phase II diagnostic clinical trial to
explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients.
Detailed description:
TCR-FAPI can covalently bind to FAP that increase tumor uptake and tumor retention in
pre-clinical studies, which elevates the ability for cancer imaging and facilitates the
targeted radionuclide therapy. This study is an open-labeled single-arm phase II
diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in
suspected malignant tumor patients. Quantitative features (i.e., SUVmax) will be
calculated to evaluate the PET images. Alternative imaging modality, including but not
limited to, Ultrasound, CT, MRI, and PET/CT with other radiotracers, might be applied
according to clinical needs. For patients who took surgery after multiple examination,
tumor tissue and histopathology will also be obtained. For patients who underwent other
treatment, treatment response of each individual lesion will be observed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Suspected to have malignant tumors (supported by MRI and/or CT and/or tumor markers
and/or pathology report), the tumor may be newly diagnosed or previously treated;
- Meet the indications for PET examination, show a clear indication and no
contraindications;
- Have a performance status of score ≥ 80 on KPS scale or score 0-1 points on ECOG
scale, a relatively good general situation;
- No major organ dysfunction (heart, lung, liver, kidney and other major organ
include), acute or life-threatening status of infection;
- Be ≥ 18 years of age;
- Be willing and able to understand the research content and provide written informed
consent/assent for the trial.
Exclusion Criteria:
- Have a history of imaging agent allergies;
- Does not meet the PET-CT scan sedation requirements, or has contraindications for
PET-CT examination;
- Be pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhibo Liu, Ph.D.
Phone:
0086-010-62751715
Email:
zbliu@pku.edu.cn
Start date:
May 5, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Peking University
Agency class:
Other
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06084767
