Spots Global Cancer Trial Database for 68-Ga-DOTATATE PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: 68-Ga-DOTATATE PET-CT Scan for Diagnosis of Primary and Metastatic Somatostatin Receptor-positive Neuroendocrine Tumors (NETs)

Official Title: 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)

Study ID: NCT01879657

Conditions

Neuroendocrine Carcinoma

Interventions

68Ga-DOTATATE injection and PET scan

Study Description

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.