The proposed research combines two emerging technologies, Cerenkov Luminescence Imaging (CLI) and Gallium-68 PSMA (68Ga-PSMA), in order to assess surgical margins during prostate cancer surgery. CLI involves imaging of a faint light emitted from…
ID
Source
Brief title
Condition
- Prostatic disorders (excl infections and inflammations)
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the present study is to assess the feasibility of the
CLI device as margin assessor intraoperatively in prostate cancer patients.
Secondary outcome
• Tumour margin status of the prostatectomy specimen as determined by LightPath
CLI and histopathology
• Radiation dosimetry to the OR personnel during the radical prostatectomy
• Tumour uptake on 68Ga-PSMA LightPath CLI in comparison to 68Ga-PSMA PET with
high resolution
• Ease of use of LightPath CLI
• Imaging protocol optimization for ex vivo prostate specimens and the
determination of the optimal radiation dosage.
Background summary
Prostate cancer is the leading cancer among men in the Netherlands. Surgery
remains the primary treatment, yet it is frequently unsuccessful with cancer
left behind. Incomplete removal of cancer during prostate surgery is associated
with increased likelihood of disease recurrence, and hence, additional
treatments are necessary in these cases. Complete surgical excision is
challenging, as the surgeon is unable to distinguish between cancerous and
non-cancerous tissue during surgery. Therefore there is an urgent medical need
to visualize cancer in real time during an operation to ensure that all of the
cancer is completely removed.
Study objective
The proposed research combines two emerging technologies, Cerenkov Luminescence
Imaging (CLI) and Gallium-68 PSMA (68Ga-PSMA), in order to assess surgical
margins during prostate cancer surgery. CLI involves imaging of a faint light
emitted from radioactive molecules. Radioactive molecules, like Ga-68, are
already used in oncology diagnostics to visualize tumours with PET scanners.
68Ga-PSMA is a highly specific and sensitive agent for prostate cancer,
promising the potential for accurate CLI images that can improve surgical
decision-making. Within this study an adapted CLI-device will be used for the
first time in humans using 68Ga-PSMA. If feasible, the research will
significantly advance a technique that holds the potential to lower the number
of positive surgical margins.
Study design
This is a prospective observational feasibility study
A clinical feasibility study in small group of prostate cancer patients (n =
30). Included patients scheduled for a prostate resection will get a Ga68- PSMA
injection (100MBq) on the operating room, thereafter undergo resection
according to local clinical protocol. All resected specimens and lymph nodes
will be imaged with the CLI technology before transfer to the pathology
department. CLI-outcomes will be related to Ga68-PSMA uptake on PET and
histological examination.
After the first 5 patients an interim analysis will be performed, which will
assess the administered dose, the radiation exposure and the procedure. The
dose could be altered, with a maximum of total administered dose 200MBq. With
the increase of the dose, the radiation safety will be monitored, whether or
not this increase is justified. The first 15 patients will be used to optimize
the protocol and workflow. With the last 15 patients the resected prostate
after CLI, will be imaged with the PET scan. To match the uptake on the CLI to
the PET-scan. Based on the outcomes of this feasibility study a new prospective
trial will be developed.
Additionally, the precense of 68Ga-PSMA uptake in these tissues will be
cross-validated with a mobile radiation detector.
Intervention
The administration of 100MBq 68Ga-PSMA prior to CLI imaging.
Study burden and risks
The patient will be intravenous injected with 68Ga-PSMA during surgery. Thus
giving additional radiation dosage to the patient. This will approximately be
2mSv. This falls within the diagnostic range, therefore not expected to be
harmful to the patient.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- Primary prostate cancer >18 year, eligible for PSMA PET scan (PSA>=20 ng/mL
or >=cT3 or Gleason>=7)
- Tumour larger than 2cm on MRI.
- Signed informed consent
- Voluntary understanding
- Scheduled for radical prostatectomy surgery
- PSMA uptake on pre-operative 68Ga-PSMA PET scan
Exclusion criteria
- Usage of Indocyanine green (ICG) during surgery
- No PSMA uptake on clinical PET/CT-scan
- Subjects who have an existing medical condition that would compromise their
participation in the study
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 | NL66218.031.18 |