MedTrace Logo

68Ga-HSA PET/CT Imaging for Protein-losing Enteropathy

NCT06716788 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-12-04

No results posted yet for this study

Summary

In this project, based on the DTPA-HAS kit, investigators plan to develop a positron nuclide 68Ga labeled DTPA-HSA molecular probe in order to obtain high sensitivity, signal-to-noise ratio and high-resolution PET/CT imaging images, aiming to find the specific site of intestinal leakage while diagnosing Protein-Losing Enteropathy (PLE), and analyze the pathological mechanism of intestinal leakage in combination with pathology, so as to provide molecular imaging guidance for the treatment of PLE patients. PLE is a rare gastrointestinal protein-losing syndrome, and the radiopharmaceutical 99mTc-DTPA-HSA (99mTc-human serum albumin) approved by the State Food and Drug Administration has the diagnostic ability of protein-losing enteropathy (PLE), but due to the low resolution of SPECT/CT, the image clarity and signal-to-noise ratio need to be improved, it is a classic probe in the last century, unable to meet the existing clinical needs.

Conditions

Interventions

DRUG

68Ga-HSA

68Ga-HSA PET/CT: after intravenous injection of 2.22 MBq/kg body weight of quality-controlled 68Ga-HSA, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.

Sponsors & Collaborators

  • Suzhou Transcenta Therapeutics Co., Ltd.

    collaborator INDUSTRY

  • Peking University Cancer Hospital & Institute

    lead OTHER

Principal Investigators

  • Hua Zhu · Peking University Cancer Hospital & Institute

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2025-12-31
Completion
2026-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716788 on ClinicalTrials.gov