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

NCT06716788 | Not Yet Recruiting DMC

• 1 other identifier: 2023YJZ61
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

PET/CT; Protein-Losing Enteropathy; 68Ga labeling; Human serum albumin

Outcome Measures

Primary Outcomes (2)

• Standard Uptake Value Value

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

  1 year

• SUVR

  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)

  1 year

Study Arms (1)

68Ga-HSA PET/CT in participants with hypoproteinemia

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.

Drug: 68Ga-HSA

Interventions

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.

Also known as: 68Ga-DTPA-HSA

68Ga-HSA PET/CT in participants with hypoproteinemia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at Being Cancer Hospital who are confirmed protein-losing enteropathy, or digestive system tumors with hypoproteinemia.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Suzhou Transcenta Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Neoplasms; Protein-Losing Enteropathies

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hua Zhu

  Peking University Cancer Hospital & Institute

  STUDY DIRECTOR

Central Study Contacts

Dan Li

CONTACT

+86 010-88196495; 17839949055@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: December 4, 2024
• Study Start: May 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: May 31, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)