CLO20-034: First U.S. Prospective Evaluation of Performance of 64Cu DOTATATE PET/CT in Somatostatin Expressing Neuroendocrine Tumors

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  • a Excel Diagnostics and Nuclear Oncology Center, Houston, TX
  • b RadioMedix, Houston, TX

Introduction: 68 Ga-labeled Somatostatin (SST) analogues are highly sensitive and specific PET radiopharmaceuticals for imaging SST expressing neuroendocrine tumors (NET). However, their major shortcomings are short half-life of 68 minutes, dependency on Ga-68 generator, and hence availability only in limited geographical regions. Cu-64 DOTATATE addresses all these shortcomings with half-life of 12.6 hours, cyclotron production, centralized high scale manufacturing and distribution throughout the country. Objective: The study aim was to prospectively evaluate the safety and diagnostic performance of 64 Cu-DOTATATE PET/CT in detection of SST expressing NET. Method: All subjects received 4.0 ± 10% mCi of 64 Cu-DOTATATE and PET/CT imaging was performed 60 ± 15 minutes after injection. PET/CT images were read by three independent nuclear medicine physicians blinded to clinical information. Separately, Independent oncologist determined disease or no disease as well as local or metastatic status of the subject, from all available Standard of Truth (SOT) pathology, clinical, and conventional imaging studies. A total of 63 subjects were considered for statistical analysis. Results: All the images were of high quality. Reader 1 had a sensitivity and specificity of 91% and 97%; reader 2 of 91% and 80%, and reader 3 of 91% and 90%, respectively. It is important to note that failures in detecting disease were retrospectively reviewed by the investigators after the database was locked. Upon review of these failures it was noted that three SOT image reads determined to be positive for disease by the oncologist, were in fact negative for disease. Each of these subjects had their primary tumor resected prior and anatomical imaging confirming no evidence of disease prior to determining the SOT and as such should have had a SOT determined as “no disease”. Taking this into account, for readers 1 & 3 and the majority read would have had a sensitivity of 100%, specificity of 96.8%, PPV of 96.7%, NPV of 100%, and accuracy of 98.4 %. Reader 2 would have had a sensitivity of 100%, specificity of 81.8%, PPV of 83.3%, NPV of 100%, and accuracy of 90.5%. All patients tolerated 64 Cu-DOTATATE well, with no serious adverse reactions. Conclusion: 64 Cu-DOTATATE PET/CT is a safe imaging technique that provides high quality images (figure) and excellent accuracy (98%) for detection of SST expressing NETs.

Figure
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Maximum intensity projection image (A) of a patient with metastatic small bowel carcinoid tumor. Small (yellow arrow points to a 3 mm lesion) omental and peritoneal tumor implants are seen on the PET/CT fused image (B), and the correcponding CT image (C).

Citation: Journal of the National Comprehensive Cancer Network J Natl Compr Canc Netw 18, 3.5; 10.6004/jnccn.2019.7422

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Corresponding Author: E.S. Delpassand, MD
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    Maximum intensity projection image (A) of a patient with metastatic small bowel carcinoid tumor. Small (yellow arrow points to a 3 mm lesion) omental and peritoneal tumor implants are seen on the PET/CT fused image (B), and the correcponding CT image (C).

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