Metastatic Ovarian Cancer Clinical Trial
Official title:
Biodistribution, Tumor Detection, and Radiation Dosimentry of [18F]-AZAFOL as POSITRON EMISSION TOMOGRAPHY (PET) Tracer in Folate Receptor Positive Cancer Imaging
This is a clinical trial category C as this is a first in man trial with an unapproved
investigational product. Nevertheless the risk is considered low due to the low dose ≤ 10μg.
No toxicity effects were observed preclinically at a dose >1000 -fold the intended dose.
Open-labeled, non-blinded, non-placebo controlled, multicenter study.
Primary objective:
Assessment of biodistribution and FR-specific tumor detection of [18F]- AzaFol as a PET
imaging agent in patients with FR-positive and FR-negative metastatic cancer of the ovaries
or lungs.
Secondary objective:
Calculation of the effective dose to the patient according to the tissue distribution data of
[18F]-AzaFol (Dosimetry)
Human research study using a radiopharmaceutical product to reveal folate receptor (FR)
expression in tumors in patients.
It is known that the FR is overexpressed on a variety of tumor types. FR-positive tumors can
be treated with investigational drugs specifically targeting the FR.
Although the FR-expression status may be determined by immunohistochemical staining of tumor
biopsies there is a need for a non-invasive method to determine the presence of the FR on
primary tumors and metastases in humans. For this purpose a radiopharmaceutical product will
be used as a radiotracer. Positron Emission Tomography (PET) is an imaging method which
allows assessing the distribution of radiotracers (called PET tracer). With this imaging
method it is possible to obtain (semi)quantitative measures of FR-expression on tumors of at
least 4-10 mm diameter in patients.
Such a folate-based radiotracer would be a very helpful tool to non-invasively discriminate
FR-positive (often found in ovarian and NSC-lung cancer) from FR-negative tumors in patients
with cancer disease as this would allow selecting FR-positive patients amenable to
FR-targeted therapies, e.g. folate-targeted antimitotic substances such as EC145
VintafolideTM (Endocyte Inc.) or anti-FR-antibodies such as FarletuzumabTM (Morphotek Inc).
Moreover, [18F]-AzaFol PET could be used for tumor staging and monitoring therapy as well as
for follow-up investigations of patients with FR-positive tumors.
Currently there is a radiopharmaceutical product for research purposes available (99mTc-EC20,
EtarfolatideTM, Endocyte Inc.) which can be used for Single Photon Emission Computed
Tomography (SPECT) imaging. SPECT, however, has multiple limitations compared to PET, such as
inferior spatial resolution, soft tissue attenuation, lack of dynamic acquisition etc.
Therefore, a PET-compound for FR imaging has been shown to image FR-positive tumors in
experimental animals .
Calculations regarding the incidence and mortality of six frequent cancer types in
Switzerland indicate that in over 53% of the new cases the FR is expressed (OncoSuisse,
Cancer Statistics 2012).
Investigators demonstrate impressively why FR-targeting emerged as an attractive strategy for
tumor diagnosis and for the development of new targeted therapy strategies .
The vitamin folic acid (pteroylglutamic acid) emerged as an almost ideal FR-targeting agent
because of the high affine binding to the FR (KD < 1 nM).
Due to the small size and vitamin character of folic acid, it is non-immunogenic and
non-toxic.
In spite of a large number of folate-based nuclear imaging agents which have been developed
in the last two decades only one SPECT radiotracer (99mTc-EC20, EtarfolatideTM) is currently
being used in clinical trials in the U.S. for SPECT imaging. For over a decade investigators
have been focusing research activities on the development of a 18F-based folate radiotracer
for PET imaging (13-16). Recently, a novel folate radiotracer has been developed,
3'-aza-3-[18F]fluorofolic acid (herein referred to as [18F]-AzaFol), for PET imaging
purposes.
Compared to SPECT, PET is the more sensitive nuclear imaging method which provides images of
an improved resolution and the possibility for accurate quantification of accumulated
radioactivity in tumor lesions.
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