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

Primary Purpose

Neuroendocrine Tumors

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
68Ga-DOTATOC
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumors

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    68Ga-DOTATOC PET/CT

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Specificity to Detect True Negative
    A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).

    Full Information

    First Posted
    April 5, 2017
    Last Updated
    May 7, 2023
    Sponsor
    Montefiore Medical Center
    Collaborators
    NCM USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03136328
    Brief Title
    Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
    Official Title
    Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    May 16, 2016 (Actual)
    Primary Completion Date
    March 2017 (Actual)
    Study Completion Date
    March 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Montefiore Medical Center
    Collaborators
    NCM USA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    68Ga-DOTATOC PET/CT
    Arm Type
    Experimental
    Arm Description
    Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
    Intervention Type
    Drug
    Intervention Name(s)
    68Ga-DOTATOC
    Other Intervention Name(s)
    Diagnostic test
    Intervention Description
    The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
    Primary Outcome Measure Information:
    Title
    Sensitivity to Correctly Diagnose NET
    Description
    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.
    Time Frame
    During imaging process ( approximately 120 minutes)
    Secondary Outcome Measure Information:
    Title
    Specificity to Detect True Negative
    Description
    A tumor is an abnormal growth of cells which can be malignant or not. NET tumors secrete hormones that will disrupt the normal ecology of the body. 68Ga-DOTATOC is extremely sensitive and specific to the receptors expressed by NET. These attributes are unique to 68Ga-DOTATOC and makes it the only imagining technique that can determine whether or not lesions detected by conventional imaging is due to NET involvement. 68Ga-DOTATOC is able to exclude disease involvement in lesions detected on CT/MRI; this ability to exclude disease involvement is called Specificity. The reported values indicate the specificity of 68Ga-DOTATOC, which is the percentage of tumors detected by conventional imagining that 68Ga-DOTATOC correctly determined were not due to NET involvement (i.e. identifying true negative for NET).
    Time Frame
    During imaging process ( approximately 120 minutes)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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: 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Charito Love, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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