Nuklearmedizin 2021; 60(02): 134
DOI: 10.1055/s-0041-1726707
Leuchtturm
Bildgebung und Therapie

The CCK-2 receptor agonist Lu-177-PP-F11N for PRRT of medullary thyroid cancer – Recent results of the phase 1 “LUMED” Study

C Rottenburger
1   University Hospital Basel, Division of Nuclear Medicine, Basel, Switzerland
,
G Nicolas
1   University Hospital Basel, Division of Nuclear Medicine, Basel, Switzerland
,
L McDougall
1   University Hospital Basel, Division of Nuclear Medicine, Basel, Switzerland
,
M Fürstner
2   Inselspital Bern, Department of Nuclear Medicine, Bern, Switzerland
,
M Hentschel
2   Inselspital Bern, Department of Nuclear Medicine, Bern, Switzerland
,
F Kaul
1   University Hospital Basel, Division of Nuclear Medicine, Basel, Switzerland
,
ER Christ
3   University Hospital Basel, Division of Endocrinology, Diabetology and Metabolism, Basel, Switzerland
,
M Cachovan
4   Siemens Healthcare GmbH, Forchheim, Germany
,
HA Vija
5   Siemens Medical Solutions USA, Hoffman Estates, USA
,
R Schibli
6   Paul Scherrer Institute, Center for Radiopharmaceutical Sciences, Villigen, Switzerland
,
S Geistlich
6   Paul Scherrer Institute, Center for Radiopharmaceutical Sciences, Villigen, Switzerland
,
M Béhé
6   Paul Scherrer Institute, Center for Radiopharmaceutical Sciences, Villigen, Switzerland
,
D Wild
1   University Hospital Basel, Division of Nuclear Medicine, Basel, Switzerland
› Author Affiliations
› Further Information
 

Ziel/Aim Recently, we demonstrated that the administration of the novel CCK-2 receptor agonist Lu-177-DOTA-(DGlu)6-Ala-Tyr-Gly-Trp-Nleu-Asp-PheNH2 (Lu-177-PP-F11N) is safe and enables for visualization of metastasized disease in patients with medullary thyroid carcinoma. This subsequent phase 1 study aims to determine the maximum tolerated dose of Lu-177-PP-F11N (ClinicalTrials.gov: NCT02088645). Here, we present the resent results of the dose escalation study.

Methodik/Methods All patients examined to date (n = 3) received three injections of 6 GBq Lu-177-PP-F11N in an interval of 8 weeks. Planar scintigraphy and SPECT/CT scans were performed at several time points for up to 72 h post injection in order to calculate tumor and organ radiation doses. Blood samples were taken for bone marrow dose calculations as well as measurement of blood count and blood chemistry. Follow-up will be performed until two years after the last injection.

Ergebnisse/Results Adverse reactions (mainly hot flashes, nausea and hyperhidrosis) after injection of Lu-177-PP-F11N were comparable to the phase 0 study and not higher than grade 2 according to CTCAE version 4.03. Follow up visits after at least 3 months after the last injection did not reveal any dose limiting toxicity in all patients. Radiation doses to organs were below critical levels. The median (range) radiation dose for metastases (n = 7) was 0.88 Gy/GBq (0.34-2.41), resulting in a median cumulative dose of 16.8 Gy (6.4-47.5). Maximum reduction of CEA was in median 7.9 % (range: 6.5-33.7) at 7.1 months (median) after first infusion. Calcitonin reduction occurred in only one patient (7.7 % after 6.3 months).

Schlussfolgerungen/Conclusions The administration of the novel CCK-2 receptor ligand Lu-177-PP-F11N at a potentially therapeutic dose was observed to be safe in all patients of the first dose escalation cohort. Based on this outcome and the results of tumor and organ dosimetry, the cumulative administrated activity dose administered (18 GBq) will be further increased in the next escalation cohort.



Publication History

Article published online:
08 April 2021

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