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Impact of Peptides and Chelators on Somatostatin Receptor Antagonists

Primary Purpose

Neuroendocrine Tumors

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 PET/CT

68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 PET/CT

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring somatostatin receptor antagonist, PET/CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, 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.

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

LM3 group

NODAGA group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Lesion numbers

Determination of lesion numbers of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.

Standard uptake value (SUV)

Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.

Secondary Outcome Measures

Full Information

NCT ID

NCT04491851

First Posted

July 27, 2020

Last Updated

November 3, 2020

Sponsor

Peking Union Medical College Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04491851

Brief Title

Impact of Peptides and Chelators on Somatostatin Receptor Antagonists

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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, and NODAGA-JR11, all labeled with gallium-68.

Detailed Description

Patients will be randomly assigned into two arms: Arm A : 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B : 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 In each arm, patients will undergo PET/CT using assigned tracers. Lesion detection, lesion SUV, and the tumor-to-background ratio will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors

Keywords

somatostatin receptor antagonist, PET/CT

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomly assigned into four arms: Arm A : 68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 Arm B : 68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11

Masking

ParticipantOutcomes 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.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LM3 group

Arm Type

Experimental

Arm Description

Arm Title

NODAGA group

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 PET/CT

Intervention Description

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.

Intervention Type

Diagnostic Test

Intervention Name(s)

68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 PET/CT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Lesion numbers

Description

Determination of lesion numbers of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.

Time Frame

At 1-hours post-injection

Title

Standard uptake value (SUV)

Description

Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-LM3, 68Ga-DOTA-LM3, and 68Ga-NODAGA-JR11 scan.

Time Frame

At 1-hours post-injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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, 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenjia Zhu, MD

Phone

+86 18614080164

zhuwenjia_pumc@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Li Huo, MD

Phone

+86 13910801986

huoli@pumch.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wenjia Zhu, MD

Organizational Affiliation

Peking Uion Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yupei Zhao, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Impact of Peptides and Chelators on Somatostatin Receptor Antagonists

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