Request for Pre-Approval
68Ga-DOTA-NOC
PET/CT for Evaluation of Neuroendocrine Cancer
RE: ___________________________ (Patient Name and Identifier)
Dr. ___________________________, who is treating Mr./Ms. ________________,
believes that management of this patient’s clinical care would be advanced by performance of a
68Ga-DOTA-NOC PET/CT scan.
The clinical indication for this 68Ga-DOTA-NOC PET/CT study is:
☐
Neuroendocrine cancer patient who is potentially a candidate for treatment by
multivisceral transplant.
☐
Patient in whom a biopsied liver mass has been found to be a neuroendocrine
tumor (presumably metastatic), and whose treatment requires detection of the
unknown primary tumor and/or definition of the extent of disease.
☐
Patient in whom prior, clinically indicated, 111In-Octreoscan SPECT has failed to
address the clinical diagnostic need, and for whom a 68Ga-DOTA-NOC PET/CT
study is clinically judged to be in the patient’s best interest for advancing decisions
about their medical care.
(Prior Octreoscan Study Date: ________________)
The Indiana University School of Medicine can produce the 68Ga-DOTA-NOC
radiopharmaceutical for this patient under Physician-Sponsored Expanded Access IND #117255
(James W. Fletcher, M.D., Sponsor).
The 68Ga-DOTA-NOC radiopharmaceutical is a somatostatin-receptor-targeting peptide,
radiolabeled with gallium-68, that has found widespread clinical use in Europe, and that has
proven quite effective in localizing neuroendocrine tumors with PET/CT [1-10].
While related to the FDA-approved 111In-Octreotide (Octreoscan) agent for gamma and SPECT
imaging of neuroendocrine tumors, the literature shows the 68Ga-PET procedure to deliver
images with superior tumor/non-target contrast, and far better sensitivity for tumor detection
[1-10]. Our clinical experience with 68Ga-DOTA-NOC PET/CT at the Indiana University Hospital
is fully consistent with this literature.
The 68Ga-DOTA-NOC PET/CT procedure will be performed in accordance with the published
procedure guidelines of the European Association of Nuclear Medicine and Molecular Imaging
[1].
The FDA-authorized charge for this Expanded Access radiopharmaceutical is $3,013. This
charge represents the break-even cost of producing the radiopharmaceutical per patient.
The charges to the patient will be the following:
The patient charge for the dose will be $100.00.
The technical charge for performance of the PET CT scan will be $4,200.00.
The professional fee for interpretation and reporting will be $609.00.
Technical questions about the 68Ga-DOTA-NOC PET/CT procedure can be directed to:
Professor James W Fletcher, M.D.
Director of Nuclear Medicine and PET Imaging
Department of Radiology and Imaging Sciences
Indiana University School of Medicine
Indianapolis, IN 46202
317-944-1800
e-mail: jwfletch@iupui.edu
Questions about the clinical need for the 68Ga-DOTA-NOC PET/CT procedure, and how it is
expected to advance this patient’s care, should be directed to:
___________________________, M.D.
Department of __________________________
Indiana University School of Medicine
Indianapolis, IN 46202
317-__________________
e-mail: _________________
The 68Ga-DOTA-NOC PET/CT study cannot be performed for this patient without confirmation
that payment will be made for the procedure.
For reference, Blue Cross of Arkansas has issued a favorable coverage decision for such 68GaPET evaluation of neuroendocrine tumors:
http://www.arkansasbluecross.com/members/report.aspx?policyNumber=2001039&viewIntro=yes
Literature References
1.
I. Virgolini, V. Ambrosini, J.B. Bomanji, R.P. Baum, S. Fanti, M. Gabriel, N.D.
Papathanasiou, G. Pepe, W. Oyen, C. De Cristoforo, A. Chiti. Procedure guidelines for
PET/CT tumour imaging
with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68GaDOTA-NOC, 68Ga-DOTA-TATE, Eur J Nucl Med Mol Imaging (2010) 37:2004–2010.
2.
D. Wild, H.R. Mäcke, B. Waser et al. 68Ga-DOTANOC: A first compound for PET imaging
with high affinity for somatostatin receptor subtypes 2 and 5 Eur J Nucl Med Mol Imaging,
32 (2005), p. 724.
3.
V. Prasad, R.P. Baum Biodistribution of the Ga-68 labeled somatostatin analogue DOTANOC in patients with neuroendocrine tumors: Characterization of uptake in normal organs
and tumor lesions Q J Nucl Med Mol Imaging, 54 (2010), pp. 61–67.
4.
V. Rufini, M.L. Calcagni, R.P. Baum Imaging of neuroendocrine tumors Semin Nucl Med,
36 (2006), pp. 228–247.
5.
V. Prasad, V. Ambrosini, M. Hommann et al. Detection of unknown primary
neuroendocrine tumors(CUP-NET) using (68)Ga-DOTA-NOC receptor PET/CT Eur J Nucl
Med Mol Imaging, 37 (2010), pp. 67–77.
6.
Baum R, Niesen A, Leonhardi J, Wortmann R, Mueller D, Roesch F. Receptor PET/CT
imaging of neuroendocrine tumors using the Ga-68 labelled, high affinity somatostatin
analogue DOTA-1-Nal3 octreotide (DOTA-NOC): clinical results in 327 patients. Eur J Nucl
Med Mol Imaging 2005;32 Suppl 1:S54–5.
7.
Valentina Ambrosini, Davide Campana, Lisa Bodei, Cristina Nanni, Paolo Castellucci,
Vincenzo Allegri, Gian Carlo Montini, Paola Tomassetti, Giovanni Paganelli, and Stefano
Fanti. 68Ga-DOTANOC PET/CT Clinical Impact in Patients with Neuroendocrine Tumors,
J Nucl Med 2010; 51:669–673.
8.
Antunes P, Ginj M, Zhang H, Waser B, Baum RP, Reubi JC, et al. Are radiogallium-labelled
DOTA-conjugated somatostatin analogues superior to those labelled with other
radiometals? Eur J Nucl Med Mol Imaging (2007) 34(7):982–93.
9.
C. Pettinato, A. Sarnelli, M. Di Donna, S. Civollani, C. Nanni, G. Montini, D. Di Pierro, M.
Ferrari,
M. Marengo, C. Bergamini. 68Ga-DOTANOC: biodistribution and dosimetry in
patients affected by neuroendocrine tumors, Eur J Nucl Med Mol Imaging (2008) 51:72–
79.
10. D Wild, JB. Bomanji, P Benkert, H Maecke, PJ. Ell, JC Reubi, ME Caplin. Comparison of
68Ga-DOTANOC and 68Ga-DOTATATE PET/CT within patients with
gastroenteropancreatic neuroendocrine tumors, J Nucl Med (2013) 54:364–372.