MedDataX Logo

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

NCT ID: NCT06716788

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

68Ga-HSA

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

68Ga-DTPA-HSA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Suzhou Transcenta Therapeutics Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hua Zhu

Role: STUDY_DIRECTOR

Peking University Cancer Hospital & Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Dan Li

Role: CONTACT

Phone: +86 010-88196495

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hua Zhu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023YJZ61

Identifier Type: -

Identifier Source: org_study_id