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NCT Number: NCT06716788

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

68Ga-HSA

Drug

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.

Other names: 68Ga-DTPA-HSA

Primary outcomes

  1. Standard Uptake Value Value

    Time frame: 1 year

    The standardized uptake value(SUV) of 68Ga-HSA in suspected PLE lesions measured by the PET/CT

  2. SUVR

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

  • Suzhou Transcenta Therapeutics Co., Ltd.

Registry information

Official study title

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

Acronym: PLE-PET

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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