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

P

Peking University Cancer Hospital & Institute

Status

Not yet enrolling

Conditions

Cancer

Treatments

Drug: 68Ga-HSA

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT06716788
2023YJZ61

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

50 participants in 1 patient group

68Ga-HSA PET/CT in participants with hypoproteinemia
Description:
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.
Treatment:
Drug: 68Ga-HSA

Trial contacts and locations

1

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Central trial contact

Dan Li

Data sourced from clinicaltrials.gov

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