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Impact of Peptides and Chelators on Somatostatin Receptor Antagonists

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: NCT04491851
Recruitment Status : Not yet recruiting
First Posted : July 29, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
Somatostatin receptor antagonists are emerging agents in molecular imaging of neuroendocrine tumors. There're two main antagonist peptides, namely JR11 and LM3, which can be coupled with different chelators, DOTA and NODAGA. Previous studies by our and other groups have revealed the different diagnostic performances of these tracers. However, head-to-head comparison data is still missing. In this study, we aim to evaluate the diagnostic performance of four different antagonists, that is, NODAGA-LM3, DOTA-LM3, NODAGA-JR11, and DOTA-JR11, all labeled with gallium-68.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Diagnostic Test: 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 PET/CT Diagnostic Test: 68Ga-NODAGA-JR11 and 68Ga-DOTA-JR11 PET/CT Diagnostic Test: 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 PET/CT Diagnostic Test: 68Ga-DOTA-LM3 and 68Ga-DOTA-JR11 PET/CT Phase 2

Detailed Description:

Patients will be randomly assigned into four arms:

Arm A (LM3 Arm): 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B (JR11 Arm): 68Ga-NODAGA-JR11 and 68Ga-DOTA-JR11 Arm C (NODAGA Arm): 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 Arm D (DOTA Arm): 68Ga-DOTA-LM3 and 68Ga-DOTA-JR11

In each arm, patients will undergo PET/CT using two of the four tracers. Lesion detection, lesion SUV, and the tumor-to-background ratio will be compared.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients will be randomly assigned into four arms:

Arm A (LM3 Arm): 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B (JR11 Arm): 68Ga-NODAGA-JR11 and 68Ga-DOTA-JR11 Arm C (NODAGA Arm): 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 Arm D (DOTA Arm): 68Ga-DOTA-LM3 and 68Ga-DOTA-JR11

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 Study to Evaluate the Impact of Different Peptides and Chelators on the Diagnostic Performance of PET/CT Using Gallium-68 Labeled Somatostatin Receptor Antagonists
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A (LM3 Arm)
In this arm, patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
Diagnostic Test: 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 PET/CT
Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.

Experimental: Arm B (JR11 Arm)
In this arm, patients will undergo PET/CT using 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) and 68Ga-DOTA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
Diagnostic Test: 68Ga-NODAGA-JR11 and 68Ga-DOTA-JR11 PET/CT
Patients will undergo PET/CT using 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) and 68Ga-DOTA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.

Experimental: Arm C (NODAGA Arm)
In this arm, patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
Diagnostic Test: 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 PET/CT
Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.

Experimental: Arm D (DOTA Arm)
In this arm, patients will undergo PET/CT using 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
Diagnostic Test: 68Ga-DOTA-LM3 and 68Ga-DOTA-JR11 PET/CT
Patients will undergo PET/CT using 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.




Primary Outcome Measures :
  1. Lesion numbers [ Time Frame: At 1-hours post-injection ]
    Determination of lesion numbers of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, 68Ga-NODAGA-JR11, and 68Ga-DOTA-JR11 scan.

  2. Standard uptake value (SUV) [ Time Frame: At 1-hours post-injection ]
    Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, 68Ga-NODAGA-JR11, and 68Ga-DOTA-JR11 scan.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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 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 the upper limit of 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 JR11 or to any of the excipients of Gallium-68 DOTA-LM3, Gallium-68 NODAGA-LM3, Gallium-68 DOTA-JR11, or Gallium-68 NODAGA-JR11.
  • 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 scans.
  • Proofs of negative somatostatin receptor expression by previous scans or Immunohistochemical staining results.
  • 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): NCT04491851


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

Locations
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China, Beijing
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Contact: Yupei Zhao, MD         
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Principal Investigator: Wenjia Zhu, MD Peking Uion Medical College Hospital
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04491851    
Other Study ID Numbers: ANTANET
First Posted: July 29, 2020    Key Record Dates
Last Update Posted: July 30, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peking Union Medical College Hospital:
somatostatin receptor antagonist
PET/CT
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue