Clinical trial · Observational
68Ga-HSA PET/CT Imaging for Protein-losing Enteropathy
Development and Clinical Translation of Protein-losing Enteropathy (PLE) Imaging PET Probe
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-HSA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Drug: 68Ga-HSA
Primary outcomes (2)
- measure
- Standard Uptake Value Value
- timeFrame
- 1 year
- description
- The standardized uptake value(SUV) of 68Ga-HSA in suspected PLE lesions measured by the PET/CT
- measure
- SUVR
- timeFrame
- 1 year
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available