Neuroendocrine Carcinoma
Conditions
Brief summary
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.
Detailed description
The number of lesions that could be identified clearly as single foci will be determined for each patient. The same anatomic areas will be imaged with 68Ga-DOTATATE PET and 111In-penteoctreotide Scintigraphy to ensure relevant comparison of lesion detection. Because of confluence and inability to clearly delineate single liver lesions in some cases, liver metastases will be classified as 1 organ metastasis, independent of the number of liver metastases present. Lymph nodes smaller than 1 cm on CT or MRI and showing marked avidity for 68Ga- DOTATATE and 111In-penteoctreotide will be labeled as positive for disease. The presence of lesions will be confirmed by cross-sectional imaging of all patients with CT or MRI.
Interventions
DRUG68Ga-DOTATATE
68Ga-DOTATATE (3-5 mCi ±25%; 111-185 MBq) is administered as a single intravenous bolus injection in each participant. These injections were performed within 28 days after the Octreoscan.
DIAGNOSTIC_TESTPET/CT
68Ga-DOTATATE PET images will be acquired 60 ±30 minutes after injection of 68Ga-DOTATATE. 68Ga-DOTATATE PET images were performed within 28 days after the Octreoscan.
DIAGNOSTIC_TEST111In-pentetreotide OctreoScan
OctreoScan™ was performed after intravenous injection of 111In-pentetreotide, a radiopharmaceutical that binds to somatostatin receptors, if the patient had not undergone such imaging as a standard of care. Subsequent planar and/or SPECT imaging was used to detect somatostatin receptor-positive lesions.
DIAGNOSTIC_TESTMRI
MRI (Standard of Care)
Sponsors
Radiomedix, Inc.
Excel Diagnostics and Nuclear Oncology Center
Radio Isotope Therapy of America
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions detected by 68GA-DOTATATE compared to conventional imaging technique | SOT within 28 days before 68Ga-DOTATATE PET/CT scan | We want to determine if the 68Ga-DOTATATE PET/CT scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and severity of Adverse Events | 4 days | Adverse events will be collected from the time of 68Ga-DOTATATE injection until 48 hours post-injection visit. Adverse events will be classified using criteria for adverse events (CTCAE) Version 4. |
Countries
United States
Outcome results
None listed