The primary objective of this study is to proof the principle of imaging a tumour in-vivo, with Cerenkov radiation.Furthermore we want to determine the difficulties and limiting factors for in-vivo CLI. Determine the SNR (Signal to Noise) and the…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main question is whether we ara able to image the uptake of 18F-FDG in a
human tumour, in-vivo, with a stand alone EMCCD camera. The primary study
parameter is if we can subjectively distinguish the tumour from the background.
Secondary outcome
Secondary study parameters are the signal to noise ratio between the tumour and
healthy tissue. With that we take the actual uptake and the depth of the tumour
into account.
Background summary
During tumour resection it is important to remove all the malignant tissue
without compromising functional and cosmetic outcomes. To achieve this surgeons
the surgeons should be able to distinguish malignant from healthy tissue.
Several techniques are available to assist the surgeon in localizing the tumor.
However, for the assessment of malignant versus healthy tissue the surgeon
depends mostly on sight and tactile sense. For some tumours this is a difficult
task. Especially when there is a disturbed anatomy and fibroses due to prior
surgery or radiation.
To localize the tumor and to prevent positive resection margins a technique to
visualize the tumor intraoperatively is of much value to the surgeon.
Cerenkov luminescence imaging (CLI) is a new technique that combines PET with
optical imaging and has therefore the possibility to image tumours
intraoperatively. Cerenkov radiation is a natural phenomenon that occurs when
charged particles travel through a medium, faster than the speed of light in
that particular medium. This also occurs with PET tracers in the human body.
The Cerenkov radiation is manifests in emitting a very small amount of photons
that can be measured in a light tight area with a high sensitivity EMCCD Camera.
The combination of FDA approved tumour specific PET tracers with a high
resolution mobile camera offers the possibilities to develop an image guided
surgery device.
Study objective
The primary objective of this study is to proof the principle of imaging a
tumour in-vivo, with Cerenkov radiation.
Furthermore we want to determine the difficulties and limiting factors for
in-vivo CLI. Determine the SNR (Signal to Noise) and the Cerenkov radiation
signal due to physiological uptake.
Study design
Observational pilot study
Study burden and risks
Based on the proceedings of this study we do not expect additional risks for
the patient. For the purpose of this study the patients will have to undergo
additional CLI in a light tight room. The CLI procedure will be non-invasive.
Patients have to lie on an examination bed with the tumour uncovered presented
to the camera. Multiple images will be made with acquisition time varying from
1 to 300 seconds. During the acquisition the imaged part of the body should not
be moved. The maximum amount of time the additional imaging will take is 30
minutes. For this investigation no extra measures have to be taken for the
patients.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
Patients, older than 18 years, who will receive and 18F-FDG PET-CT scan and have a superficial tumour, <3 cm from surface, that shows sufficient uptake of 18F-FDG.
Exclusion criteria
Patient younger than 18 years.
Patients with a melanoma with a high melanin level.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52499.031.15 |