68-Ga-DOTATATE PET-CT Scan for Diagnosis and Staging of Neuroendocrine Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2013 |
| End Date: | August 2016 |
| Contact: | Ebrahim S Delpassand, MD |
| Email: | edelpassand@radiomedix.com |
| Phone: | 713-499-9733 |
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.
OctreoScan ® which is considered standard of care diagnostic test for neuroendocrine cancers
and other imaging modalities like CT scan/MRI as gold standard.
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.
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.
Inclusion Criteria:
- Patients of either gender, aged at least 18 years.
- Karnofsky status equal or greater than 60.
- Life expectancy of at least 12 weeks.
- Histologically and/or clinically confirmed and/or suspicious of NET.
- Somatostatin-analogue scintigraphies scan with result (positive or negative) within
the last 4 weeks.
- Recent Blood test results up to 2-3 weeks as follows:(WBC:equal/higher 2*109/L;
Haemoglobin: equal/higher 8.0g/Dl; Platelets: equal/higher 50x109/L; ALT, AST, AP:
equal/lower 5 times ULN; Bilirubin: equal/lower 3 times 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 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.
We found this trial at
1
site
Houston, Texas 77042
Principal Investigator: Ebrahim S Delpassand, MD
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