ACR–ACNM–ARS–SNMMI PRACTICE PARAMETER FOR LUTETIUM-177 (Lu-177) DOTATATE THERAPY

PREAMBLE

I. INTRODUCTION

II. INDICATIONS

III. QUALIFICATIONS AND RESPONSIBILITIES OF PERSONNEL

IV. SPECIFICATIONS OF THE EXAMINATION AND TREATMENT

V. DOCUMENTATION

VI. STATEMENT OF THERAPEUTIC USE OF UNSEALED RADIOPHARMACEUTICAL SOURCES

VII. EQUIPMENT SPECIFICATIONS

VIII. RADIATION SAFETY

IX. QUALITY CONTROL AND IMPROVEMENT, SAFETY, INFECTION CONTROL, AND PATIENT EDUCATION

ACKNOWLEDGEMENTS

REFERENCES

1. [-3197650] American College of Radiology. ACR-AAPM-ACNM-SNMMI Technical Standard for Therapeutic Procedures Using Radiopharmaceuticals. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=153+&releaseId=2
2. [18565894] Yao JC, Hassan M, Phan A, et al. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72.
3. [28263217] Hamiditabar M, Ali M, Roys J, et al. Peptide Receptor Radionuclide Therapy With 177Lu-Octreotate in Patients With Somatostatin Receptor Expressing Neuroendocrine Tumors: Six Years' Assessment. Clin Nucl Med. 2017 Jun;42(6):436-443.
4. [18445841] Kwekkeboom DJ, de Herder WW, Kam BL, et al. Treatment with the radiolabeled somatostatin analog [177 Lu-DOTA 0,Tyr3]octreotate: toxicity, efficacy, and survival. J Clin Oncol. 26(13):2124-30, 2008 May 01.
5. [25273832] Bodei L, Kidd M, Paganelli G, et al. Long-term tolerability of PRRT in 807 patients with neuroendocrine tumours: the value and limitations of clinical factors. Eur J Nucl Med Mol Imaging. 2015 Jan;42(1):5-19.
6. [29497803] Garske-Román U, Sandström M, Fröss Baron K, et al. Prospective observational study of 177Lu-DOTA-octreotate therapy in 200 patients with advanced metastasized neuroendocrine tumours (NETs): feasibility and impact of a dosimetry-guided study protocol on outcome and toxicity. Eur J Nucl Med Mol Imaging. 2018 Jun;45(6):970-988.
7. [28076709] Strosberg J, El-Haddad G, Wolin E, et al. Phase 3 Trial of (177)Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med 2017;376:125-35.
8. [22388631] Kam BL, Teunissen JJ, Krenning EP, et al. Lutetium-labelled peptides for therapy of neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2012 Feb;39 Suppl 1(Suppl 1):S103-12.
9. [20554737] Vegt E, de Jong M, Wetzels JF, et al. Renal toxicity of radiolabeled peptides and antibody fragments: mechanisms, impact on radionuclide therapy, and strategies for prevention. J Nucl Med. 2010 Jul;51(7):1049-58.
10. [8099808] Hammond PJ, Wade AF, Gwilliam ME, et al. Amino acid infusion blocks renal tubular uptake of an indium-labelled somatostatin analogue. Br J Cancer. 1993 Jun;67(6):1437-9.
11. [12582815] Jamar F, Barone R, Mathieu I, et al. 86Y-DOTA0)-D-Phe1-Tyr3-octreotide (SMT487)--a phase 1 clinical study: pharmacokinetics, biodistribution and renal protective effect of different regimens of amino acid co-infusion. Eur J Nucl Med Mol Imaging. 30(4):510-8, 2003 Apr.
12. [18427807] Bodei L, Cremonesi M, Ferrari M, et al. Long-term evaluation of renal toxicity after peptide receptor radionuclide therapy with 90Y-DOTATOC and 177Lu-DOTATATE: the role of associated risk factors. Eur J Nucl Med Mol Imaging. 2008 Oct;35(10):1847-56.
13. [15653656] Valkema R, Pauwels SA, Kvols LK, et al. Long-term follow-up of renal function after peptide receptor radiation therapy with (90)Y-DOTA(0),Tyr(3)-octreotide and (177)Lu-DOTA(0), Tyr(3)-octreotate. J Nucl Med. 2005 Jan;46 Suppl 1():83S-91S.
14. [26419852] Bergsma H, Konijnenberg MW, Kam BL, et al. Subacute haematotoxicity after PRRT with (177)Lu-DOTA-octreotate: prognostic factors, incidence and course. Eur J Nucl Med Mol Imaging. 2016 Mar;43(3):453-63.
15. [27353035] Bodei L, Modlin IM, Luster M, et al. Myeloid neoplasms after chemotherapy and PRRT: myth and reality. Endocr Relat Cancer. 2016 Aug;23(8):C1-7.
16. [23389427] Bodei L, Mueller-Brand J, Baum RP, et al. The joint IAEA, EANM, and SNMMI practical guidance on peptide receptor radionuclide therapy (PRRNT) in neuroendocrine tumours. Eur J Nucl Med Mol Imaging. 2013 May;40(5):800-16.
17. [18210106] de Keizer B, van Aken MO, Feelders RA, et al. Hormonal crises following receptor radionuclide therapy with the radiolabeled somatostatin analogue [177Lu-DOTA0,Tyr3]octreotate. Eur J Nucl Med Mol Imaging. 2008 Apr;35(4):749-55.
18. [30464038] Huang K, Brenner W, Prasad V. Tumor Lysis Syndrome: A Rare but Serious Complication of Radioligand Therapies. J Nucl Med. 2019 Jun;60(6):752-755.
19. [-3197834] American College of Radiology. ACR-AAPM radiation safety officer resources. Available at: https://www.acr.org/-/media/ACR/Files/Radiology-Safety/Radiation-Safety/ACRAAPM-RSO-Resources.pdf?la=en. .
20. [-3197883] American College of Radiology. ACR-ARS Practice Parameter for Radiation Oncology. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=200+&releaseId=2
21. [-3197882] American College of Radiology. ACR-ARS Practice Parameter for Communication: Radiation Oncology. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=199+&releaseId=2
22. [24434296] Ezziddin S, Attassi M, Yong-Hing CJ, et al. Predictors of long-term outcome in patients with well-differentiated gastroenteropancreatic neuroendocrine tumors after peptide receptor radionuclide therapy with 177Lu-octreotate. J Nucl Med. 55(2):183-90, 2014 Feb.
23. [-3197671] American College of Radiology. ACR-ACNM-SNMMI-SPR Practice Parameter for the Performance of Neuroendocrine Tumor Scintigraphy. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=92+&releaseId=2
24. [-3197668] American College of Radiology. ACR–ACNM–SNMMI Practice Parameter for the Performance of Gallium-68 and Copper-64 DOTATATE PET/CT Imaging for Neuroendocrine Tumors. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=18+&releaseId=2
25. [-3197699] American College of Radiology. ACR-ARS Practice Parameter on Informed Consent- Radiation Oncology. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=141+&releaseId=2
26. [31263080] Hope TA, Abbott A, Colucci K, et al. NANETS/SNMMI Procedure Standard for Somatostatin Receptor-Based Peptide Receptor Radionuclide Therapy with 177Lu-DOTATATE. J Nucl Med. 2019 Jul;60(7):937-943.
27. [-3197835] United States Nuclear Regulatory Commission. NRC policy on release of iodine-131 therapy patients under 10 CFR 35.75 to locations other than private residences. RIS 2011-01. Available at: https://www.nrc.gov/docs/ML1036/ML103620153.pdf.
28. [-3197830] United States Nuclear Regulatory Commission. Consolidated guidance about materials licenses: program-specific guidance about medical use licenses (NUREG-1556, Volume 9, Revision 2). Available at: http://www.nrc.gov/reading-rm/doc-collections/nuregs/staff/sr1556/v9/r2/.
29. [-3197836] National Council on Radiation Protection and Measurements. NCRP No. 155, management of radionuclide therapy patients. Available at: https://ncrponline.org/publications/reports/ncrp-reports-155/. .
30. [17043624] Bakker WH, Breeman WA, Kwekkeboom DJ, De Jong LC, Krenning EP. Practical aspects of peptide receptor radionuclide therapy with [177Lu][DOTA0, Tyr3]octreotate. Q J Nucl Med Mol Imaging. 2006 Dec;50(4):265-71.
31. [29949416] Mittra ES.. Neuroendocrine Tumor Therapy: 177Lu-DOTATATE. [Review]. AJR Am J Roentgenol. 211(2):278-285, 2018 08.
32. [-3197837] Advanced Accelerator Applications. Highlights of prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf.
33. [-3197885] American College of Radiology. ACR–AAPM Technical Standard for Nuclear Medical Physics Performance Monitoring of Gamma Cameras. Available at https://gravitas.acr.org/PPTS/GetDocumentView?docId=196+&releaseId=2

Appendix A