Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan

NCT ID: NCT03136328

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-16
• Study Completion Date: 2017-03-31

Brief Summary

The primary goal of the analysis is to estimate the diagnostic accuracy of Gallium 68 (68Ga) -DOTATOC PET/CT for detecting neuroendocrine tumors (NETs) compared to conventional imaging techniques such as Magnetic Resonance Imaging (MRI) and Computerized Tomography (CT). Participants with histologically and/or clinically confirmed and/or suspected NET will be enrolled.

Detailed Description

This is a prospective, Phase 2, single center study of participants with Neuroendocrine Tumors (NETs). Study participants will receive 68Ga-DOTATOC. DOTATOC is a somatostatin analogue that localizes on the somatostatin receptors expressed by NETs and is attached to a radioactive material called Gallium 68. Participants will undergo a PET/CT imaging study to investigate 68Ga-DOTATOC's suitability as a positron emission tomography (PET) imaging agent for NETs. The radiation (imaging) dose will be 111-185 megabecquerel (MBq) (3 - 5 mCi) ± 25%. All doses after labeling will be presented in buffered solution for intravenous injection. Imaging will start 90 ±30 minutes after injection.

Sensitivity and specificity of this imaging technique will be compared with those of conventional imaging modality including CT, MRI and In-111 Octreoscan performed within 6-12 months before or after PET/CT.

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-DOTATOC PET/CT

Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.

Group Type: EXPERIMENTAL

68Ga-DOTATOC

Intervention Type: DRUG

The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.

Interventions

68Ga-DOTATOC

The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.

Intervention Type: DRUG

Other Intervention Names

Diagnostic test

Eligibility Criteria

Inclusion Criteria

• Signed informed consent.
• Patients of either gender, aged ≥18 years.
• Karnofsky status ≥60.
• Life expectancy of at least 12 weeks.
• Histologically and/or clinically confirmed and/or suspicious of NET.
• A diagnostic CT or MRI of the tumour region or suspected area within the previous 12 weeks prior to dosing day is available.
• Somatostatin-analogue scintigraphy scan with result (positive or negative) within the last 12 weeks.
• Recent Blood test results up to 4-6 weeks as follows:

1. White Blood Cell (WBC): >2*109/L

2. Haemoglobin: >8.0g/Dl

3. Platelets: >50x109/L

4. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)

5. Bilirubin less than, or equal to, three times its ULN

• Serum creatinine: within normal range or <120μmol/L for patients aged 60 years or older.
• Negative pregnancy test in women capable of child-bearing.

Exclusion Criteria

• Known hypersensitivity to Gallium 68, DOTATOC or to any of the excipients of 68Ga-DOTATOC.
• Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (Long Acting Release) (within 28 days) and Sandostatin® (within 2 days) prior to study imaging. If a patient is on Sandostatin® LAR a wash-out phase of 28 days is required before the injection of the study drug.
• Pregnant or breast-feeding women.
• Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NCM USA

UNKNOWN

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charito Love, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-06-274

Identifier Type: -

Identifier Source: org_study_id