Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 53 of 2991 for:    Neuroendocrine Tumors | Neuroendocrine Tumors

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318561
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Diagnostic Test: Gallium-68 NODAGA-LM3 PET/CT Diagnostic Test: Gallium-68 DOTA-LM3 PET/CT Diagnostic Test: Gallium-68 DOTATATE PET/CT Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Gallium

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 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.

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.




Primary Outcome Measures :
  1. Blood pressure[Safety and tolerability] [ Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals. ]
    Measured in millimetre of mercury.

  2. Heart rate[Safety and tolerability] [ Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals. ]
    Measured in beats per minute.

  3. Pulse oximetry[Safety and tolerability] [ Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals. ]
    Measured in percentage.

  4. Electrocardiogram QT interval[Safety and tolerability] [ Time Frame: Within 1 hour prior to the administration of radiopharmaceuticals. ]
    3-lead electrocardiogram

  5. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318561


Contacts
Layout table for location contacts
Contact: Wenjia Zhu, MD +86 18614080164 zhuwenjia_pumc@163.com
Contact: Li Huo, MD +86 13910801986 huoli@pumch.cn

Locations
Layout table for location information
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Yupei Zhao, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Layout table for investigator information
Principal Investigator: Wenjia Zhu, MD Peking Uion Medical College Hospital
Layout table for additonal information
Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04318561    
Other Study ID Numbers: LM3NT
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue