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

NCT06716788 — Not yet recruiting, 50 participants, Peking University Cancer Hospital & Institute

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Development and Clinical Translation of Protein-losing Enteropathy (PLE) Imaging PET Probe

Registry	NCT06716788, acronym PLE-PET
Status	Not yet recruiting
Study type	Observational
Enrollment	50 (Estimated)
Sponsor	Peking University Cancer Hospital & Institute (Other); collaborators: Transcenta Therapeutics (Hangzhou) Co., Ltd.
Conditions	Cancer
Interventions	68Ga-HSA (Drug)
Dates	start 2025-05-01 (estimated), primary completion 2025-12-31 (estimated), completion 2026-05-31 (estimated), first posted 2024-12-04, last updated 2024-12-04
Locations	1 site in China

-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.

Expand all sections · Collapse all

+Detailed description

This project developed a a new type of nuclide Ga-68 labeled DTPA-HSA probe, and with the inherent advantages of this nuclear medicine department, it has promoted the formulation of the production filing standard of the drug, and obtained the 68Ga-HSA injection that can be used for preclinical research and meets the clinical standards. Clinical research on 68Ga-HSA PET/CT imaging was carried out to provide a basis for the diagnosis and treatment of PLE patients.

+Arms and interventions

Arm	Type	Interventions	Description
68Ga-HSA PET/CT in participants with hypoproteinemia		Drug: 68Ga-HSA	Participants who are with hypoproteinemia will be injected with 2.22 MBq/kg body weight of 68Ga-HSA in one dose intravenously and then undergo PET/CT scan within 1 h.

68Ga-HSA (Drug), also known as 68Ga-DTPA-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.

+Outcome measures

Primary outcomes

Standard Uptake Value Value [1 year]: The standardized uptake value(SUV) of 68Ga-HSA in suspected PLE lesions measured by the PET/CT
SUVR [1 year]: Ratio of the SUV of 68GA-DTPA-HSA in the suspected PLE lesions to the SUV of 68Ga DTPA-HSA in the normal tissues corresponding to the PLE (SUVR)

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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;

+Locations (1)

Facility	City	Country	Status
Beijing Cancer Hospital	Beijing, Beijing Municipality	China

+Investigators

Hua Zhu, Study director, Peking University Cancer Hospital & Institute