Clinical trial · Interventional
68Ga-DOTATATE PET-CT for Diagnosis of Neuroendocrine Tumors (NETs)
An Open-label, Single-dose, Clinical Trial of 68Ga-DOTATATE (GalioMedix™) PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)
NCT01879657CI-TRIAL-00093181completedN/AClinicalTrials.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)
To evaluate the concordance and discordance between results of 68Ga-DOTATATE PET-CT scan and OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers and other imaging modalities like CT scan/MRI as gold standard.
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 Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 111In-pentetreotide OctreoScan | Diagnostic Test | — | UNRESOLVED |
| 68Ga-DOTATATE | Drug | — | UNRESOLVED |
| MRI | Diagnostic Test | — | UNRESOLVED |
| PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTATATE
- description
- All participants will be injected with 68Ga-DOTATATE approximately 60 minutes before PET/CT scan.
- interventionNames
- Drug: 68Ga-DOTATATE
- Diagnostic Test: PET/CT
- Diagnostic Test: 111In-pentetreotide OctreoScan
- Diagnostic Test: MRI
Primary outcomes (1)
- measure
- Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique
- timeFrame
- SOT within 28 days before 68Ga-DOTATATE PET/CT scan
- description
- We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI).
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Subjects of either sex, aged ≥18 years * Histologically and/or clinically confirmed and/or suspected NET and/or A diagnostic imaging study including but not limited to CT or MRI or FDG PET/CT, NaF PET/CT, bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day * Recent Blood test results (within 2-4 weeks predose) as WBC: ≥2 x 109/L, Haemoglobin: ≥8.0 g/dL, Platelets: ≥50 x 109/L, ALT, AST, AP:≤ 5 times ULN \[ ULN for ALT, AST and AP is 70, 20 and 20 Units/I respectively\], Bilirubin: ≤3 times ULN \[ULN for total bilirubin is 1.3mg/dL\] * Serum creatinine: Serum creatinine: \<170 μmol/L * egative pregnancy test in women capable of child-bearing Exclusion Criteria: * Known hypersensitivity to DOTA, to 68Gallium, to Octreotate or to any of the excipients of 68Ga-DOTATATE * Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (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.