Gallium-68 Labeled LM3 PET/CT in Neuroendocrine Tumors (PET)

December 20, 2021 updated by: Peking Union Medical College Hospital

A Prospective, Randomized, Double-blinded Study to Evaluate the Safety, Biodistribution, Dosimetry and Lesion Detection Ability of Gallium-68 Labeled LM3 for the Diagnostic Imaging of Metastatic, Well-differentiated Neuroendocrine Tumors Using PET/CT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with histologically confirmed metastatic, well-differentiated neuroendocrine tumors will be recruited in this study.

All patients will be randomized into two groups: Gallium-68 NODAGA-LM3 group and Gallium-68 DOTA-LM3 group.

The study will be divided into the following 2 parts:

Part ONE, which will enroll 16 patients (8 in each group), focuses on the safety evaluation, biodistribution, and dosimetry. In Part A, patients 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 or Gallium-68 DOTA-LM3 (according to their group).

Part TWO, which will enroll 24 patients (12 in each group) and follows Part A study, focuses on lesion detection ability. In Part B, patients will undergo one whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3 or Gallium-68 DOTA-LM3 (according to their group).

All patients need to do a Gallium-68 DOTATATE PET/CT scan (40ug/150-200MBq, 1h post-injection) for comparison on the next day.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gallium-68 NODAGA-LM3 group
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/CT
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.
Diagnostic test: Gallium-68 DOTATATE PET/CT
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.
Experimental: Gallium-68 DOTA-LM3 group
Patients will undergo a Gallium-68 DOTA-LM3 PET/CT as well as a Gallium-68 DOTATATE PET/CT.
Diagnostic test: Gallium-68 DOTATATE PET/CT
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.
Diagnostic test: Gallium-68 DOTA-LM3 PET/CT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure[Safety and tolerability]
Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals.
Measured in millimetre of mercury.
Within 1 hour prior to the administration of radiopharmaceuticals.
Heart rate[Safety and tolerability]
Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals.
Measured in beats per minute.
Within 1 hour prior to the administration of radiopharmaceuticals.
Pulse oximetry[Safety and tolerability]
Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals.
Measured in percentage.
Within 1 hour prior to the administration of radiopharmaceuticals.
Electrocardiogram QT interval[Safety and tolerability]
Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals.
3-lead electrocardiogram
Within 1 hour prior to the administration of radiopharmaceuticals.
Incidence of adverse effect[Safety and tolerability]
Time Frame: From right after tracer injection to 24-hours post-injection
According to version 4.03 of the Common Terminology Criteria for Adverse Events.
From right after tracer injection to 24-hours post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax (maximum concentration achieved in units of Bq/ml)
Time Frame: From right after tracer injection to 2-hours post-injection
Determination of Cmax for target lesion and discernible organs
From right after tracer injection to 2-hours post-injection
Tmax (time to achieve Cmax)
Time Frame: From right after tracer injection to 2-hours post-injection
Determination of Tmax for target lesion and discernible organs.
From right after tracer injection to 2-hours post-injection
Standard uptake value (SUV)
Time Frame: From right after tracer injection to 2-hours post-injection
Determination of SUV for detected lesions and discernible organs of 68Ga-DOTA-LM3, 68Ga-NODAGA-LM3, and 68Ga-DOTATATE scan.
From right after tracer injection to 2-hours post-injection
Lesion numbers
Time Frame: From right after tracer injection to 2-hours post-injection
Determination of lesion numbers of 68Ga-DOTA-LM3, 68Ga-NODAGA-LM3, and 68Ga-DOTATATE scan.
From right after tracer injection to 2-hours post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Wenjia Zhu, MD, Peking Uion Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 21, 2020

First Posted (Actual)

March 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 21, 2021

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LM3NT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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