HypoglycaemiaNCT06759740
An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas
A study testing 68Ga-DOTA-SEMA in people with Hypoglycaemia, run by The Affiliated Hospital Of Southwest Medical University at 1 site in China.
Trial summary
Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoglycaemia
- What is being tested?
- 68Ga-DOTA-SEMA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
- Age ≥ 18 years.
- Normal renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min, and estimated glomerular filtration rate (eGFR) > 80 mL/min/1.73 m²).
- Recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause).
- Negative for sulfonylurea drugs and insulin autoantibodies.
- ECOG performance status ≤ 2, able to tolerate the examination.
- All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.
Who cannot join
- History of allergy or hypersensitivity to the components or excipients of the investigational drug.
- Claustrophobia or inability to tolerate imaging procedures for other reasons.
- Clinically significant active infection as determined by the investigator.
- History or current presence of uncontrolled primary or metastatic brain tumors.
- Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to:
- Poorly controlled diabetes.
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- Congestive heart failure.
- Myocardial infarction within the past 12 months.
- Uncontrolled and unstable hypertension.
- Chronic kidney disease or liver disease.
- Severe pulmonary diseases.
- Poor compliance and inability to complete study procedures as expected.
- Any other conditions that the investigator considers unsuitable for participation in the clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 64600
About this study
Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas.
- Conditions
- Hypoglycaemia
- Being tested
- 68Ga-DOTA-SEMA
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTA-SEMARadiation
68Ga-DOTA-SEMA is GLP1R imaging agent
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Radiation: 68Ga-DOTA-SEMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose to major organs and tumors
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Why it stopped: The investigator did not plan to carry out this study and voluntarily withdrew it
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycaemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital Of Southwest Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Yang, The Affiliated Hospital Of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759740
- Sponsor's protocol ID
- AHSWMU-2024-072
- Status last verified
- Dec 2024
- First submitted
- 28 Dec 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas
- ClinicalTrials.gov ID
- NCT06759740
- Acronym / sponsor ID
- AHSWMU-2024-072
- Conditions
- Hypoglycaemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigator did not plan to carry out this study and voluntarily withdrew it
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Affiliated Hospital Of Southwest Medical UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jan 2025 (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.
Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Radiation: 68Ga-DOTA-SEMA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
- Age ≥ 18 years.
- Normal renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min, and estimated glomerular filtration rate (eGFR) > 80 mL/min/1.73 m²).
- Recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause).
- Negative for sulfonylurea drugs and insulin autoantibodies.
Key exclusion criteria (13 listed)
- History of allergy or hypersensitivity to the components or excipients of the investigational drug.
- Claustrophobia or inability to tolerate imaging procedures for other reasons.
- Clinically significant active infection as determined by the investigator.
- History or current presence of uncontrolled primary or metastatic brain tumors.
- Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to:
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-DOTA-SEMA68Ga-DOTA-SEMA is GLP1R imaging agent | Radiation | Experimental group |
Primary outcome
Radiation dose to major organs and tumors
Time frame: 7 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-DOTA-SEMA in people with Hypoglycaemia, run by The Affiliated Hospital Of Southwest Medical University 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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 14 Mar 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dose to major organs and tumors (time frame: 7 days). 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 14 Mar 2025.