Clinical trial · Interventional
Diagnosis and Staging of Neuroendocrine Tumors (NETs) Utilizing 68Ga-DOTATOC PET/CT Scan
NCT03136328CI-TRIAL-00066258completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTATOC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTATOC PET/CT
- description
- Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study.
- interventionNames
- Drug: 68Ga-DOTATOC
Primary outcomes (1)
- measure
- Sensitivity to Correctly Diagnose NET
- timeFrame
- During imaging process ( approximately 120 minutes)
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.