68Ga-HSA PET/CT Imaging for Protein-losing Enteropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-HSA.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Clinical Translation of Protein-losing Enteropathy (PLE) Imaging PET Probe
Overview
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.
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.
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.
Primary outcome measures
- Standard Uptake Value Value [Time frame: 1 year]
- SUVR [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Patients with digestive system tumors;
- Presence of hypoproteinemia or clinical manifestations of hypoplasma protein;
- Serum albumin <30 g/L, AAT>80 ml/d;
- Measurable lesions in imaging;
- Predicted survival greater than 3 months;
Exclusion criteria
- Severe hepatic or renal dysfunction;
- Pregnant or nursing;
- Known allergy to the investigational drug or its excipients in study;
- Unable to comply with the PET/CT imaging procedures;
- Claustrophobia or other psychiatric disorders;
- Other conditions deemed unsuitable for participation in the trial;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06716788 · 2023YJZ61