Phase 3
N=11
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT03136328 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Sensitivity to Correctly Diagnose NET — 75; 75; 100; 75 percent of NET correctly diagnosed
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 68Ga-DOTATOC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity to Correctly Diagnose NET |
75; 75; 100; 75; 100; 40 | — |
| SECONDARY Specificity to Detect True Negative |
100; 100 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03136328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.