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

NCT03136328 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 15-06-274
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• Sensitivity to Correctly Diagnose NET

  Sensitivity to detect NET will be assessed and compared with conventional imaging modality. Sensitivity is the ability of an agent to indicate the presence and location of NET. The ability of 68Ga-DOTATOC to localize more effectively to somatostatin receptors and the exquisite spatial resolution of PET/CT should make easier detection of primary and metastatic neuroendocrine tumors and allow better measurement of tumor burden. Sensitivity is the percentage of accurately diagnosed NET cases. All participants underwent conventional imaging with either Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) as standard care prior to 68Ga-DOTATOC imaging.

  During imaging process ( approximately 120 minutes)

Secondary Outcomes (1)

• Specificity to Detect True Negative

  During imaging process ( approximately 120 minutes)

Study Arms (1)

68Ga-DOTATOC PET/CT

EXPERIMENTAL

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

Drug: 68Ga-DOTATOC

Interventions

68Ga-DOTATOC DRUG

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

Also known as: Diagnostic test

68Ga-DOTATOC PET/CT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• White Blood Cell (WBC): \>2\*109/L
• Haemoglobin: \>8.0g/Dl
• Platelets: \>50x109/L
• Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline phosphatase (AP) each less than, or equal to, 5 times its Upper Limit of Normal (ULN)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montefiore Medical Center: lead
• NCM USA: collaborator

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Ga(III)-DOTATOC

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Results Point of Contact

• Title: Charito Love, MD
• Organization: Montefiore Medical Center

clove@montefiore.org

718-406-8462

Study Officials

• Charito Love, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: May 2, 2017
• Study Start: May 16, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 9, 2023
• Results First Posted: January 30, 2019

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share