TheranosticTrials.org

Clinical Trial · NCT06843629

Clinical Application of PET Imaging Targeting MSLN in Malignant Tumors

Overview

The project aims to perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed pancreatic cancer, ovarian cancer, lung adenocarcinoma and other malignant tumors with high MSLN expression and healthy volunteers, using targeted MSLN-specific imaging agents (taking \[68Ga\]Ga-NOTA-MSLN antibody fragment as an example), to achieve the following purposes: Patients with malignant tumors: for diagnosis and staging of diseases, comparing with the gold standard pathological diagnosis, evaluating diagnostic efficacy, clarifying the presence or absence of lesions, and determining the location and nature of lesions; comparing with \[18F\]FDG PET for accurate staging, evaluating the tumor load, and helping to determine the therapeutic plan. Healthy volunteers: Pharmacokinetic analysis will be performed to clarify the distribution and metabolism of the drug in the body and its safety.

Sponsor

Norwegian University of Science and Technology

Contacts

Xiaoli Lan, PhD (CONTACT)

lxl730724@hotmail.com

0086-027-83692633

Xiaoli Lan, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT06843629

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

NOTA-MSLN antibody fragment

Isotope(s):
Target(s):
  • MSLN
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA

Eligibility

Inclusion

  • The subject or his/her legal representative is able to sign and date the informed consent form;
  • Adult patients or healthy volunteers (aged 18 or above) of either sex;
  • A commitment to comply with the research procedures and to cooperate in the implementation of the full research process;
  • Patients with clinically suspected or confirmed malignant tumors such as pancreatic cancer, ovarian cancer, or lung adenocarcinoma (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc., and histological pathology examination, etc.) and in good general condition;
  • * Each subject must meet all enrollment criteria to be eligible to participate in the study:

Exclusion

  • Patients with known hypersensitivity to MSLN antibody fragment developers or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection；
  • Have a history of comorbid drug use;
  • * All subjects who meet any of the exclusion criteria baseline will be excluded from the study:
  • Those who are unable to complete a PET/MR or PET/CT examination (including inability to lie down, claustrophobia, radiophobia, etc.);
  • Having other comorbidities;