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Clinical Trials in China / NCT06716788
Starting soon Observational

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

NCT06716788 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Cancer Hospital & Institute
Phase
Observational
Started
2025-05-01
Last updated
2024-12-04

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

68Ga-HSA

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with digestive system tumors; 2. Presence of hypoproteinemia or clinical manifestations of hypoplasma protein; 3. Serum albumin \<30 g/L, AAT\>80 ml/d; 4. Measurable lesions in imaging; 5. Predicted survival greater than 3 months; Exclusion Criteria: 1. Severe hepatic or renal dysfunction; 2. Pregnant or nursing; 3. Known allergy to the investigational drug or its excipients in study; 4. Unable to comply with the PET/CT imaging procedures; 5. Claustrophobia or other psychiatric disorders; 6. Other conditions deemed unsuitable for participation in the trial;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06716788 on ClinicalTrials.gov ↗ ← All trials in China