Safety of 68Ga-DOTA-tyr3-Octreotide PET in Diagnosis of Solid Tumors

Summary

This protocol is designed to test the efficacy of 68Ga-DOTATOC PET/CT in diagnosis, staging, and measurement of response to treatment in patients with somatostatin receptor positive tumors. Goals are to 1) compare this unique PET/CT scan with the current standard of care which is a combination of Octreoscan SPECT (single photon emission tomography) plus a high resolution, contrast enhanced CT; 2) Determine the sensitivity of 68Ga-DOTATOC PET/CT in diagnosis of patients with suspected somatostatin receptor positive tumor; and 3) For those patients who have had recent treatment (e.g., surgery, chemotherapy, targeted therapy such as anti-angiogenics, kinase inhibitors, peptide receptor radiotherapy), this scan will be used to measure response to treatment. These studies will be obtained with the long term goal of submitting a New Drug Application (NDA) for FDA approval of 68Ga-DOTATOC PET/CT in adults and children.

Timeline

Start

2012-02-21

Primary completion

2017-08-27

Completion

2017-08-27

Publications

• Results Abongwa C, Mott S, Schafer B, McNeely P, Abusin G, O'Dorisio T, Zamba G, O'Dorisio MS, Menda Y. Safety and accuracy of 68Ga-DOTATOC PET/CT in children and young adults with solid tumors. Am J Nucl Med Mol Imaging. 2017 Nov 1;7(5):228-235. eCollection 2017.
• Results Menda Y, O'Dorisio TM, Howe JR, Schultz M, Dillon JS, Dick D, Watkins GL, Ginader T, Bushnell DL, Sunderland JJ, Zamba GKD, Graham M, O'Dorisio MS. Localization of Unknown Primary Site with 68Ga-DOTATOC PET/CT in Patients with Metastatic Neuroendocrine Tumor. J Nucl Med. 2017 Jul;58(7):1054-1057. doi: 10.2967/jnumed.116.180984. Epub 2017 Feb 2.

Drugs

Indications