Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04554719
Other study ID # XLan-0290
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 22, 2020
Est. completion date December 31, 2023

Study information

Verified date February 2022
Source Wuhan Union Hospital, China
Contact Xiaoli Lan, PhD
Phone 0086-027-83692633
Email lxl730724@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Positron emission tomography (PET) molecular imaging provides a valuable tool for the diagnosis and differential diagnosis, staging of various tumors. Malignant tumor is composed of tumor cells and tumor stroma, which occupies the vast majority of the tumor. Cancer-associated fibroblasts (CAF) are an important part of the tumor stroma. Fibroblast activation protein (FAP) is over-expressed in CAF, which is closely related to tumor growth, invasion, metastasis, immunosuppression and prognosis; and the expression level of FAP in normal tissues and organs is very low. So it becomes an excellent target for cancer diagnosis and treatment. Radionuclide-labeled fibroblast activation protein inhibitors (FAPI) that specifically target to FAP as a tracer for PET imaging can be applied for targeted diagnosis and treatment of cancer. Recently, some studies have found that gallium-68 (68Ga) -FAPI as a new novel positron tracer has shown to be with good application potential. In this prospective study, the investigators will use integrated PET/MR, and PET/CT with the agent 68Ga-FAPI and conventional imaging agent [F-18] fluorodeoxyglucose (18F-FDG) to diagnose and stage various cancers, the aim is to make up for the deficiency in FDG PET imaging in the diagnosis and staging of some cancers.


Description:

Positron emission tomography (PET) molecular imaging provides a valuable tool for the diagnosis and differential diagnosis, staging of various tumors. The most commonly used imaging agent is [F-18] fluorodeoxyglucose (18F-FDG), known as the "molecule of the century". However, in some low-grade gliomas, mucinous adenocarcinoma, bronchoalveolar carcinoma, primary hepatocellular carcinoma, renal clear cell carcinoma and some prostate cancers, factors such as the low expression level of tumor glucose transporter but high level of dephosphorylation, and the low number of tumor cells in tumor tissues can also be manifested as low absorption of 18F-FDG; in addition, 18F-FDG PET has limited ability to detect small lesions in some organs such as brain, liver, and kidneys that have physiological uptake or excretion of FDG with the relatively high background signal; moreover, the distribution of FDG in the body is easily affected by blood sugar. These factors limit the application value of 18F-FDG PET/CT in the differential diagnosis and staging of some malignant tumors. A malignant tumor is composed of tumor cells and tumor stroma, which occupies the vast majority of the tumor. Cancer-associated fibroblasts (CAF) are an important part of the tumor stroma. Fibroblast activation protein (FAP) is over-expressed in CAF, which is closely related to tumor growth, invasion, metastasis, immunosuppression and prognosis; and the expression level of FAP in normal tissues and organs is very low, so it becomes an excellent target for cancer diagnosis and treatment. The use of radionuclide-labeled fibroblast activation protein inhibitors (FAPI) that specifically bind to FAP as a tracer for PET imaging can be applied for targeted diagnosis and treatment of cancer. Recently, some studies have found that gallium-68 (68Ga) -FAPI as a new novel positron tracer has shown to be with good application potential. The probe has very low background uptake in different types of cancer, so it can obtain high image contrast and clear tumor boundary. And it has good stability in serum and can be quickly removed from normal organs in vivo. In this project, we plan to apply the integrated PET / MR imaging of fibroblast activating protein (FAP) in the diagnosis and staging of malignant tumors, and compare it with 18F-FDG PET / CT imaging, so as to make up for the deficiency in FDG PET imaging in the diagnosis and staging of some tumors.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging. - Subjects are able to understand and sign the informed consent voluntarily, with good compliance. Exclusion Criteria: - Acute systemic diseases and electrolyte disorders. - Pregnant or lactating women. - Patients refuse to sign the informed consent.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
68Ga-DOTA-FAPI
Intravenous access is established in advance, intravenous bolus injection, 68Ga-DOTA-FAPI dose is about 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
Device:
PET/MR
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
PET/CT
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.

Locations

Country Name City State
China China, Hubei Province Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of 68Ga-DOTA-FAPI PET/MR for diagnosis and staging in some malignant tumors. For subjects with suspected or diagnosed or treated malignant tumors who have completed 18F-FDG PET/CT imaging, diagnosis and staging results of 68Ga-DOTA-FAPI PET/MR, PET/CT will be compared to 18F-FDG PET/CT imaging, pathology, clinical and follow-up result. 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Active, not recruiting NCT02243592 - Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment
Completed NCT03445572 - Meditative Slow Breathing or Isha Kriya Meditation in Improving Cancer-Related Symptoms in Hospitalized Participants With Cancer N/A
Active, not recruiting NCT02860039 - High Dose Flu Vaccine in Treating Children Who Have Undergone Donor Stem Cell Transplant Phase 2
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT01635413 - Group Exercise Training for Functional Improvement After Treatment (The GET FIT Trial) N/A
Completed NCT00026169 - Imatinib Mesylate in Treating Patients With Advanced Cancer and Kidney Failure Phase 1
Recruiting NCT04534075 - Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial Phase 3
Active, not recruiting NCT01806129 - Reproductive Health Program in Patients With Cancer N/A
Recruiting NCT03915717 - Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring
Recruiting NCT02280161 - Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer
Recruiting NCT05520281 - Short-term Psychodynamic Psychotherapy in Serious Physical Illness N/A
Terminated NCT00532064 - Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy
Completed NCT04990882 - FAPI PET/CT Prospective Interobserver Agreement
Completed NCT01896778 - Body Warming in Improving Blood Flow and Oxygen Delivery to Tumors in Patients With Cancer N/A
Recruiting NCT05770102 - DETERMINE Trial Treatment Arm 02: Atezolizumab in Adult, Teenage/Young Adults and Paediatric Patients With Cancers With High Tumour Mutational Burden (TMB) or Microsatellite Instability-high (MSI-high) or Proven Constitutional Mismatch Repair Deficiency (CMMRD) Disposition Phase 2/Phase 3
Recruiting NCT06090266 - A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05886764 - Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials N/A
Completed NCT01432431 - Spiritual Care in Improving Quality of Life of Patients, Caregivers, and Hospital Staff N/A
Completed NCT01506440 - Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy