Investigate the distribution, dosimetry and image quality of [195mPt]cisplatin in cancer patients
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Image quality: amongst others tumour-to-background ratio and visual assessment
- Dosimetry
Secondary outcome
- eGFR
- Treatment outcome according to MTB/physician decision.
Background summary
There is a great interpatient variability in response with cisplatin treatment
and nephrotoxicity often occurs. [195mPt]cisplatin can provide useful
information about the distribution and tumour/organ uptake of cisplatin. This
information may be valuable for personalized medicine, for example for
individualized treatment selection. Most recent studies with [195mPt]cisplatin
have been performed on healthy subjects. However, cisplatin is used in patients
with solid tumours and the biodistribution of cisplatin in the tumour is
unknown and unmeasurable in healthy subjects. Other prior studies who
investigated [195mPt]cisplatin on a very small scale in humans used outdated
imaging equipment with suboptimal quantification. We now aim to explore
evaluation of the biodistribution of cisplatin in this relevant patient group
using modern imaging equipment.
Study objective
Investigate the distribution, dosimetry and image quality of [195mPt]cisplatin
in cancer patients
Study design
Pilot/proof of concept study
Study burden and risks
[195mPt]cisplatin can provide useful information about the distribution and
tumour/organ uptake of cisplatin. In the future, this information can be used
to optimize treatment with cisplatin for the individual patient. This study
does not directly benefit the subjects included in this study, but their
treatment is according to standard of care. Study patients will already be
present in het AVL for their regular treatment every day. On the first day of
the study, the patient needs to stay longer in the AVL because 2 SPECT/CTs and
planar scans will be acquired. On the other study days, no or little time extra
is needed to conduct the study.
The radiation burden of a single intravenous administration of 100 MBq
[195mPt]cisplatin will be approximately 20 mSv (1). A low dose CT causes a
radiation burden of 4 mSv. Altogether, the radiation burden for the first study
patient will be 44 mSv (20 + 6 low dose CTs *4). For comparison, one diagnostic
CT abdomen and thorax is 20 mSv.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
- > 18 years of age.
- Diagnosed with NSCLC.
- Planned for concurrent radiotherapy with cisplatin.
- At least one pulmonary tumour lesion of at least 3 cm over the longest axis.
Exclusion criteria
- Not able to provide informed consent.
- Pregnant or breastfeeding.
- Previous treatment with platinum compounds.
- Claustrophobia.
- eGFR < 60 ml/min.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2020-002861-32-NL |
| CCMO | NL74272.031.21 |