Clinical trial NCT06084767: 68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer
Official title: Evaluating the Clinical Value of 68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Tumor
Positron Emission Tomography
Fibroblast Activation Protein Inhibitor
Keywords: Malignant Tumor
Positron Emission Tomography
Fibroblast Activation Protein Inhibitor
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Peking University
name: Peking University Cancer Hospital & Institute
First posted: 2023-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 68Ga-TCR-FAPI PET/CT was used for patients with suspected malignant tumors
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 90 days
Secondary outcomes:
measure: Tumor uptake
timeFrame: 90days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shaoyan Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: