NCT04318561

Brief Summary

LM3 is a novel somatostatin receptor antagonist, while Gallium-68 DOTATATE is a typical somatostatin receptor agonist, This study is to evaluate the safety, biodistribution, dosimetry, and lesion detection ability of Gallium-68 labeled somatostatin receptor antagonist LM3 for the diagnostic imaging of metastatic, well-differentiated neuroendocrine tumors using positron emission tomography / computed tomography (PET/CT). The results will be compared between antagonist Gallium-68 labeled LM3 and agonist Gallium-labeled DOTATATE in the same group of patients. It will also be compared between the two different antagonists, Gallium-68 DOTA-LM3 and Gallium-68 NODAGA-LM3, in two parallel-designed arms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2019

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 21, 2021

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 18, 2020

Last Update Submit

December 20, 2021

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (5)

  • Blood pressure[Safety and tolerability]

    Measured in millimetre of mercury.

    Within 1 hour prior to the administration of radiopharmaceuticals.

  • Heart rate[Safety and tolerability]

    Measured in beats per minute.

    Within 1 hour prior to the administration of radiopharmaceuticals.

  • Pulse oximetry[Safety and tolerability]

    Measured in percentage.

    Within 1 hour prior to the administration of radiopharmaceuticals.

  • Electrocardiogram QT interval[Safety and tolerability]

    3-lead electrocardiogram

    Within 1 hour prior to the administration of radiopharmaceuticals.

  • Incidence of adverse effect[Safety and tolerability]

    According to version 4.03 of the Common Terminology Criteria for Adverse Events.

    From right after tracer injection to 24-hours post-injection

Secondary Outcomes (4)

  • Cmax (maximum concentration achieved in units of Bq/ml)

    From right after tracer injection to 2-hours post-injection

  • Tmax (time to achieve Cmax)

    From right after tracer injection to 2-hours post-injection

  • Standard uptake value (SUV)

    From right after tracer injection to 2-hours post-injection

  • Lesion numbers

    From right after tracer injection to 2-hours post-injection

Study Arms (2)

Gallium-68 NODAGA-LM3 group

EXPERIMENTAL

Patients will undergo a Gallium-68 NODAGA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.

Diagnostic Test: Gallium-68 NODAGA-LM3 PET/CTDiagnostic Test: Gallium-68 DOTATATE PET/CT

Gallium-68 DOTA-LM3 group

EXPERIMENTAL

Patients will undergo a Gallium-68 DOTA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.

Diagnostic Test: Gallium-68 DOTA-LM3 PET/CTDiagnostic Test: Gallium-68 DOTATATE PET/CT

Interventions

Gallium-68 NODAGA-LM3 PET/CTDIAGNOSTIC_TEST

Twenty patients will take this intervention. They will be further divided into two sub-groups with the same interventional radiopharmaceutical (Gallium-68 NODAGA-LM3) but different scanning protocols (Protocol A and Protocol B). The first enrolled 8 patients will go with Protocol A, who will undergo serial whole-body PET/CT scans at multiple time points (5m, 10m, 20m, 40m, 1h, 2h) after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3. Baseline safety assessment will be conducted right before the study. The following 12 patients will go with Protocol B, who will undergo a whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3.

Gallium-68 NODAGA-LM3 group
Gallium-68 DOTA-LM3 PET/CTDIAGNOSTIC_TEST

Twenty patients will take this intervention. They will be further divided into two sub-groups with the same intervention radiopharmaceutical (Gallium-68 DOTA-LM3) but different scanning protocols (Protocol C and Protocol D). The first enrolled 8 patients will go with Protocol C, who will undergo serial whole-body PET/CT scans at multiple time points (5m, 10m, 20m, 40m, 1h, 2h) after administering 40ug/150-200MBq Gallium-68 DOTA-LM3. Baseline safety assessment will be conducted right before the study. The following 12 patients will go with Protocol D, who will undergo a whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 DOTA-LM3.

Gallium-68 DOTA-LM3 group
Gallium-68 DOTATATE PET/CTDIAGNOSTIC_TEST

All patients have to do a Gallium-68 DOTATATE PET/CT scan (40ug/150-200MBq, 1h post-injection) for comparison on the next day of LM3 scan. Safety assessment and tolerability of the previous LM3 study will be conducted right before the study.

Gallium-68 DOTA-LM3 groupGallium-68 NODAGA-LM3 group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Patients of either gender, aged ≥ 18 years.
  • Histologically confirmed diagnosis of Metastatic, well-differentiated neuroendocrine tumor.
  • A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the tumor region within the previous 6 months prior to dosing day is available.
  • At least 1 measurable lesion based on RECIST v1.1.
  • Blood test results as follows (White blood cell: ≥ 3\*10\^9/L, Hemoglobin: ≥ 8.0 g/dL, Platelets: ≥ 50x10\^9/L, Alanine aminotransferase / Aspartate aminotransferase / Alkaline phosphatase: ≤ 5 times upper limit od normal (ULN), Bilirubin: ≤ 3 times ULN)
  • Serum creatinine: within normal limits or \< 120 μmol/L for patients aged 60 years or older.
  • Calculated Glomerular filtration rate (GFR) ≥ 45 mL/min.

You may not qualify if:

  • Known hypersensitivity to Gallium-68, to NODAGA, to DOTA, to LM3, to TATE or to any of the excipients of Gallium-68 DOTA-LM3, Gallium-68 NODAGA-LM3 or Gallium-68 DOTATATE.
  • Presence of active infection at screening or history of serious infection within the previous 6 weeks.
  • Therapeutic use of any somatostatin analog, including long-acting Sandostatin (within 28 days) and short-acting Sandostatin (within 2 days) prior to study imaging. If a patient is on long-acting Sandostatina, then a wash-out phase of 28 days is required before the injection of the study drug. If a patient is on short-acting Sandostatin, then a wash-out phase of 2 days is required before the injection of the study drug.
  • Any neuroendocrine tumor-specific treatment between antagonist and agonist scans.
  • Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
  • Pregnant or breast-feeding women.
  • Current history of any malignancy other than neuroendocrine tumor; patients with a secondary tumor in remission of \> 5 years can be included.
  • Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.

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)

  • Zhu W, Jia R, Yang Q, Cheng Y, Zhao H, Bai C, Xu J, Yao S, Huo L. A prospective randomized, double-blind study to evaluate the diagnostic efficacy of 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 in patients with well-differentiated neuroendocrine tumors: compared with 68Ga-DOTATATE. Eur J Nucl Med Mol Imaging. 2022 Apr;49(5):1613-1622. doi: 10.1007/s00259-021-05512-y. Epub 2021 Dec 7.

    PMID: 34874478DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Wenjia Zhu, MD

    Peking Uion Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The details of patient groups will be sealed in sequentially numbered, opaque, sealed envelopes generated by Xuezhu Wang from the nuclear medicine department, Peking Union Medical College Hospital, who will not participate in other parts of the study.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 24, 2020

Study Start

December 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

December 21, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)