TheranosticTrials.org

Clinical Trial · NCT07651020

The Clinical Application Value of SPECT Imaging Targeting LRRC15 in Malignant Tumors

Overview

Here's a polished version of the text: "This project involves patients with high-expression LRRC15 malignant tumors who are either clinically suspected of or diagnosed with pancreatic cancer, breast cancer, lung cancer, ovarian cancer, head and neck tumors, colorectal cancer, melanoma, etc., as well as healthy volunteers. Using a targeted LRRC15-specific SPECT imaging agent, SPECT/CT imaging is performed to achieve the following objectives: For malignant tumor patients: To support disease diagnosis and staging. Diagnostic performance will be evaluated against the gold standard of pathological diagnosis, clarifying the presence or absence of lesions and determining their location and nature. To enable accurate staging and assess tumor burden by comparison with \[18F\]FDG PET/CT, thereby aiding in the determination of treatment plans. For healthy volunteers: To conduct pharmacokinetic analysis, elucidating the distribution, metabolism, and safety profile of the agent in the body."

Sponsor

Norwegian University of Science and Technology

Contacts

Xiaoli Lan, PhD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT07651020

Drug / Compound

FDG

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

LRRC15-targeted SPECT imaging agent

Isotope(s):
Target(s):
  • Leucine-Rich Repeat Containing 15 (LRRC15)

Eligibility

Inclusion

  • The subject or their legally authorized representative (LAR) is capable of providing a signed and dated informed consent form (ICF);
  • Willing and able to comply with all study procedures and cooperate throughout the entire duration of the study;
  • Each subject must meet all of the following inclusion criteria to be eligible for study enrollment:
  • Adult patients or healthy volunteers, aged 18 years or older, male or female;
  • Patients with clinically suspected or confirmed malignancies (supported by evidence such as relevant serum tumor markers, imaging modalities including ultrasound, CT, and MRI, or histopathological examinations) who are in good general condition;

Exclusion

  • Presence of other comorbidities, such as acute systemic illnesses and electrolyte imbalances;
  • Any subject meeting any of the following baseline criteria will be excluded from the study:
  • Inability to tolerate or complete SPECT/CT examinations (including, but not limited to, the inability to lie supine, claustrophobia, radiophobia, etc.);
  • Patients deemed by the investigator to have poor expected compliance;
  • Known allergy or hypersensitivity to the LRRC15 radiotracer or its synthetic excipients; fasting blood glucose level exceeding 11.0 mmol/L prior to \[¹⁸F\]FDG injection;