NCT05034783

Brief Summary

Glucagon-like peptide-1 receptor (GLP-1R)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect insulinoma, like the widely studied \[68Ga\]Ga-NOTA-exendin-4. This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, which was compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

1 year

First QC Date

September 2, 2021

Last Update Submit

October 13, 2022

Conditions

Insulinoma

Outcome Measures

Primary Outcomes (1)

  • Metabolic parameters

    the early dynamic distribution (SUVmax in tumor lesions and SUVmean in normal organs at different time points) of \[68Ga\]Ga-HBED-CC-exendin-4 in comparison with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Diagnostic value

    through study completion, an average of 1 year

Other Outcomes (1)

  • GLP-1R expression and SUV

    through study completion, an average of 1 year

Study Arms (1)

[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan

EXPERIMENTAL

Patients of Insulinoma PET/CT imaging: In two consecutive days each patient underwent a 60-min dynamic PET/CT scan after intravenous administration of \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4, respectively.

Drug: [68Ga]Ga-HBED-CC-exendin-4Drug: [68Ga]Ga-NOTA-exendin-4

Interventions

[68Ga]Ga-HBED-CC-exendin-4DRUG

Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) \[68Ga\]Ga-HBED-CC-exendin-4. Tracer doses of \[68Ga\]Ga-HBED-CC-exendin-4 will be used to image lesions of insulinoma by PET/CT.

Also known as: [68Ga]Ga-HBED-CC-exendin-4 injection
[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan
[68Ga]Ga-NOTA-exendin-4DRUG

Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) \[68Ga\]Ga-NOTA-exendin-4. Tracer doses of \[68Ga\]Ga-NOTA-exendin-4 will be used to image lesions of insulinoma by PET/CT.

Also known as: [68Ga]Ga-NOTA-exendin-4 injection
[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/ CT scan

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed treated or untreated insulinoma patients;
  • \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4 PET/CT within two consecutive days;
  • signed written consent.

You may not qualify if:

  • pregnancy;
  • breastfeeding;
  • known allergy against exendin-4;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (1)

  • Li L, Wang G, Wang J, Ma H, Chen J, Wang R, Pan Q, Hong H, Jin W, Kung HF, Zhu L, Luo Y, Zhu Z. Glucagon-Like Peptide-1 Receptor-Targeted PET/CT With 68 Ga-HBED-CC-Exendin-4 in Localizing Insulinoma : A Head-to-Head Comparison to 68 Ga-NOTA-Exendin-4. Clin Nucl Med. 2025 Jan 1;50(1):38-43. doi: 10.1097/RLU.0000000000005533. Epub 2024 Nov 8.

    PMID: 39499011DERIVED

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet CellAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Zhaohui Zhu, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 5, 2021

Study Start

October 1, 2021

Primary Completion

October 13, 2022

Study Completion

June 1, 2023

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations

CN(1)