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

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ClinicalTrials.gov Identifier: NCT03136328
Recruitment Status : Completed
First Posted : May 2, 2017
Results First Posted : January 30, 2019
Last Update Posted : March 7, 2019
Sponsor:
Collaborator:
NCM USA
Information provided by (Responsible Party):
Charito Love, Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE April 5, 2017
First Posted Date  ICMJE May 2, 2017
Results First Submitted Date  ICMJE November 28, 2018
Results First Posted Date  ICMJE January 30, 2019
Last Update Posted Date March 7, 2019
Actual Study Start Date  ICMJE May 16, 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Neuroendocrine tumor detectability through PET/CT imaging of its somatostatin receptors. [ Time Frame: 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 ]
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.
Change History Complete list of historical versions of study NCT03136328 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2019)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2017)
Clinical significance of intensity of Ga-68 DOTATOC activity [ Time Frame: To allow followup of cases, re-assessment of lesions will be performed by investigators in 12 months through repeat SSR imaging, CT or MRI. ]
Compare the intensity of Ga-68 DOTATOC activity in NET with that of the liver and spleen through SUV measurement and visual analysis and generate Krenning scores established for NET in order to determine if there is utility of such scoring system with this PET radiopharmaceutical at initial imaging.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Official Title  ICMJE Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neuroendocrine Tumors
Intervention  ICMJE Drug: 68Ga-DOTATOC
The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
Other Name: Diagnostic test
Study Arms  ICMJE Experimental: 68Ga-DOTATOC PET/CT
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
Intervention: Drug: 68Ga-DOTATOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2017)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03136328
Other Study ID Numbers  ICMJE 15-06-274
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Charito Love, Montefiore Medical Center
Study Sponsor  ICMJE Charito Love
Collaborators  ICMJE NCM USA
Investigators  ICMJE
Principal Investigator: Charito Love, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP