Impact of Peptides and Chelators on Somatostatin Receptor Antagonists

NCT ID: NCT04491851

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-09-30

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.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

LM3 group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

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.

NODAGA group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wenjia Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Uion Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenjia Zhu, MD

Role: CONTACT

zhuwenjia_pumc@163.com

+86 18614080164

Li Huo, MD

Role: CONTACT

huoli@pumch.cn

+86 13910801986

Facility Contacts

Yupei Zhao, MD

Role: primary

Other Identifiers

ANTANET

Identifier Type: -

Identifier Source: org_study_id