TheranosticTrials.org

Clinical Trial · NCT06162988

PET Imaging of 68Ga-NOTA-H006 in Malignancy

Overview

5T4, also known as trophoblast glycoprotein, is an oncofoetal antigen expressing in fetal development and cancer but rarely in adult. The high expression of 5T4 in malignancy was found be associated with poor clinical outcomes in ovarian, gastric and colorectal cancers. Several antibody drug conjugates are currently under development for cancer therapy in preclinic and clinic stages. Previously, investigators engineered a 5T4-specific biomolecule with nanomolar binding affinity. Radiolabeling with gallium-68 resulted in 68Ga-NOTA-H006 which showed 5T4 expression in a variety of xenograft models. Thus, the aims of current study are to evaluate the distribution and dosimetry of this novel tracer, and to explore the diagnostic values of 68Ga-NOTA-H006 in malignant tumors.

Sponsor

Huashan Hospital

Phase

N/A

Contacts

Fang Xie, PhD (PRINCIPAL_INVESTIGATOR)

Yihui Guan, MD (CONTACT)

guanyihui@hotmail.com

13764308300

ClinicalTrials.gov

NCT06162988

Drug / Compound

H006

Isotope(s):
Target(s):
  • 5T4
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA

Eligibility

Inclusion

  • Have a clear histologic or pathologic diagnosis of colorectal cancer.
  • Willingness and ability to cooperate with all programs of this study.
  • Patients with CT findings of suspicious space on the lungs with a diameter of more than 1cm who have not undergone surgery.
  • Be between the ages of 18 and 65.
  • Willingness and ability to cooperate with all programs of the study.Bowel cancer clinical trial study subjects must meet all of the following criteria:

Exclusion

  • Targeted therapy prior to radiotherapy or PET/CT scan. 5T4 expression in existing lesions assessed by immunohistochemistry using antibody clones.
  • Those who have participated in other clinical trials during the same period.
  • History of serious surgery in the last month.
  • Severe hepatic or renal insufficiency;