CancerPLE-PETNCT06716788
68Ga-HSA PET/CT Imaging for Protein-losing Enteropathy
An observational study of Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- 68Ga-HSA
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 31 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Being Cancer Hospital who are confirmed protein-losing enteropathy, or digestive system tumors with hypoproteinemia.
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hua Zhu, +861088196495, zhuhuananjing@163.com
About this study
Official title: Development and Clinical Translation of Protein-losing Enteropathy (PLE) Imaging PET Probe
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.
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- 68Ga-HSA
- Keywords
- PET/CT, Protein-Losing Enteropathy, 68Ga labeling, Human serum albumin
- Medical subject headings
- Neoplasms, Protein-Losing Enteropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-HSADrug
Also called 68Ga-DTPA-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 68Ga-HSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Uptake Value Value
The standardized uptake value(SUV) of 68Ga-HSA in suspected PLE lesions measured by the PET/CT
Measured: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start1 May 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hua Zhu, Study director, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716788
- Sponsor's protocol ID
- 2023YJZ61
- Acronym
- PLE-PET
- Status last verified
- Dec 2024
- First submitted
- 15 Jan 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Translation of Protein-losing Enteropathy (PLE) Imaging PET Probe
- ClinicalTrials.gov ID
- NCT06716788
- Acronym / sponsor ID
- PLE-PET / 2023YJZ61
- Conditions
- Cancer
- Keywords
- PET/CT, Protein-Losing Enteropathy, 68Ga labeling, Human serum albumin
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Transcenta Therapeutics (Hangzhou) Co., Ltd.
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-HSA PET/CT in participants with hypoproteinemia | – | Drug: 68Ga-HSAParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Being Cancer Hospital who are confirmed protein-losing enteropathy, or digestive system tumors with hypoproteinemia.
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-HSAAlso: 68Ga-DTPA-HSA68Ga-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. | Drug | 68Ga-HSA PET/CT in participants with hypoproteinemia |
Primary outcome
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hua Zhu study director
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Peking University Cancer Hospital & Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Li (+86 010-88196495, 17839949055@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard Uptake Value Value (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.