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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03136328
Recruitment Status : Completed
First Posted : May 2, 2017
Results First Posted : January 30, 2019
Last Update Posted : March 7, 2019
Information provided by (Responsible Party):
Charito Love, Montefiore Medical Center

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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: 68Ga-DOTATOC Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Actual Study Start Date : May 16, 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: 68Ga-DOTATOC PET/CT
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
Drug: 68Ga-DOTATOC
The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
Other Name: Diagnostic test

Primary Outcome Measures :
  1. Sensitivity to Correctly Diagnose NET [ Time Frame: During imaging process ( approximately 120 minutes) ]
    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 :
  1. Specificity to Detect True Negative [ Time Frame: During imaging process ( approximately 120 minutes) ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03136328

Sponsors and Collaborators
Charito Love
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Principal Investigator: Charito Love, MD Montefiore Medical Center
  Study Documents (Full-Text)

Documents provided by Charito Love, Montefiore Medical Center:
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Responsible Party: Charito Love, Associate Professor of Radiology, Montefiore Medical Center Identifier: NCT03136328    
Other Study ID Numbers: 15-06-274
First Posted: May 2, 2017    Key Record Dates
Results First Posted: January 30, 2019
Last Update Posted: March 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Molecular Mechanisms of Pharmacological Action