A Pilot, Open-label, Proof-of-Concept Study of the Use of [18F] Fluciclatide PET/CT Imaging in the Evaluation of Anti-AngiogenicTherapy in Renal Cancers
- Fluciclatide is a small cyclic peptide containing the RGD tri-peptide, which
preferentially binds with high affinity to Alpha(v)Beta(3) integrins, which are
up-regulated in and may regulate angiogenesis.
- Alpha(v)Beta(3) integrins are also expressed on certain types of tumor cells, such as
renal cell cancer.
- [18F] Fluciclatide (previously known as 18F-AH111585) is a new radiopharmaceutical
developed for PET imaging, which targets Alpha(v)Beta(3) receptors.
- Initial and ongoing clinical studies performed in Europe and an ongoing multicenter
phase 2 proof-of-concept study (which is currently open at the NIH Clinical Center);
demonstrate to date that [18F] Fluciclatide is safe and well tolerated.
- To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of
treatment with targeted anti-angiogenic therapy in renal cell cancer.
- Adult subjects (greater than or equal to18 years old), with documented renal or
metastatic renal cancer, with at least one tumor greater than or equal to1 cm in
diameter outside of the liver, who are scheduled to enroll in a therapy protocol using
an anti-angiogenic agent.
- The subject has a platelet count of > 100,000 times 10(6)/L, hemoglobin value of > 9
g/dL, prothrombin time (PT) and an activated partial thromboplastin time (aPTT) within
< 2 times normal limits.
- The subject has not received any targeted anti-angiogenic agents within 60 days prior
to pre-treatment (baseline) [18F] Fluciclatide PET imaging.
This will be a pilot, open-label, proof-of-concept study to assess the magnitude of changes
in [18F] Fluciclatide PET tumor uptake following treatment with an anti-angiogenic therapy.
We expect to enroll 30 evaluable patients in this single center study. When possible, the
data analysis will be stratified based on the anti-angiogenic agent received. Subjects will
undergo at least two [18F] Fluciclatide PET/CT imaging studies, one pre-therapy and one
following completion of 1 cycle of therapy. An optional early post-therapy (2-7 days post
therapy commencement) [18F] Fluciclatide PET/CT may be performed. The magnitude of [18F]
Fluciclatide uptake on the preand post- treatment PET/CT studies will be evaluated to
determine if there is a measureable difference in uptake. Subjects may also undergo standard
of care imaging studies as part of routine tumor assessments specified in referring
protocols (e.g. diagnostic CT, FDG-PET/CT, etc). Data from the subject's referring therapy
protocol will be reviewed for up to one year after anti-angiogenic therapy initiation to
assess for tumor response or progression and its relationship to [18F] Fluciclatide PET/CT
imaging. Some patients will also undergo optional DCE-MRI scans of the target lesion and in
those subjects a comparison between MR parameters and [18F]
Fluciclatide parameters will be made.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To determine tumor uptake and retention of [18F] Fluciclatide before and after 1 cycle of treatment with targeted anti-angiogenic therapy in renal cell cancer.
Maria Liza Lindenberg, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|