Cancer
Conditions
Keywords
PET/CT, Protein-Losing Enteropathy, 68Ga labeling, Human serum albumin
Brief 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.
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
DRUG68Ga-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
Suzhou Transcenta Therapeutics Co., Ltd.
Peking University Cancer Hospital & Institute
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactDan Li
Outcome results
None listed