Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
This study in 20 patients is designed as a monocentric, open-label and uncontrolled,
exploratory pilot study. Patients diagnosed with advanced melanoma (stage III-IV) and
scheduled for anti-PD-1 immunotherapy will be recruited for this project. Patients will
receive IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m (bolus injection) according to
the Navidea's protocol in our GMP certified radiopharmaceutical unit, before the first cycle
of clinically scheduled immunotherapy.
Scintigraphy images will be acquired dynamically from time of injection to +30 minutes.
Quantitative SPECT/CT (xSPECT/CT, Siemens Symbia Intevo, Erlangen, Germany) imaging will be
performed up to 1 hour p.i. to evaluate hyperaemia, and up to 3 hours p.i. to image and
measure the CD206 receptor uptake. The data of the scans will be compared to
immunohistochemistry results from biopsy staining for TAMs and M2-like TAMs and
retrospectively with response to the immunotherapy to determine any correlation between
M2-like TAMs and treatment response. For the planned retrospective comparison we will use the
FDG - PET/CT data that is done after the immunotherapy as standard of care. We will analyse
the lesion size and FDG - uptake in standard of care PET/CT of CD206+ and CD206 negative
lesions in Tilmanocept SPECT/CT before and after immunotherapy to determine any correlation
between CD206 related uptake and treatment response.