PSMA PET/CT has not been applied before for this indication, or with such a low dose. Before starting the study, we would like to confirm that PSMA PET/CT provides good image quality of the salivary glands with a 50% lower administered tracer dose,…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Toxiciteit in speekselklieren van uitwendige bestraling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The image quality will be evaluated visually with respect to spatial
resolution, signal-to-noise levels and artefacts. The signal reduction due to
external beam irradiation will be interpreted visually, while considering
relatively spared regions and known normal uptake patterns in healthy gland
tissues. An expert panel will review if the PSMA PET/CT scans are adequate
(feasible) for the application in the anticipated study protocol.
Secondary outcome
Not applicable.
Background summary
High dose radiotherapy in the head-neck area can result in loss of salivary
gland function, with potential serious impact on quality of life. The relation
between the received radiation dose and the local function loss in distinct
salivary gland subtypes is insufficiently understood, and thus there are
currently no known dose constraints or sparing strategies for most gland types.
We have already demonstrated that PSMA PET/CT can visualize the presence of
acinar cells in all salivary gland locations throughout the head and neck, with
a sensitive and quantitative signal. Theoretical considerations suggest that
PSMA PET/CT of the salivary glands can be performed with a 50% lower
administered tracer dose than the clinical standard, and that a loss of vital
acinar cells after radiotherapy will result in a reduction of PSMA accumulation
in salivary glands.
We are now developing a study protocol to determine the relation between the
received radiation dose and the development of function loss of salivary
glands, separately for distinct salivary gland types and both for the long term
and acute phase, using PSMA PET/CT. This information can contribute to the
development of dose constraints and sparing strategies, to individualised and
adaptive treatment strategies, and hopefully to lower toxicity of radiotherapy
and achieve a better quality of life in treated patients.
Study objective
PSMA PET/CT has not been applied before for this indication, or with such a low
dose. Before starting the study, we would like to confirm that PSMA PET/CT
provides good image quality of the salivary glands with a 50% lower
administered tracer dose, and that it provides a measurable signal reduction in
case of clinically confirmed function loss of the salivary glands after high
dose radiotherapy.
Study design
Patients will receive a single low dose PET/CT (50 MBq Gallium-68-PSMA and low
dose CT) of the head and neck area at 6-12 months after their (CC)RT. Image
acquisition and processing will be performed according to standard clinical
protocols.
Study burden and risks
Participation in this study has no significant risks. Patients will receive one
PSMA PET/CT scan of the head-neck area, with a radiation expose of 1 mSv from
the administered 50 MBq Gallium-68-PSMA and 3 mSv from low dose CT, for a total
of 4 mSv. This is well within the range of normal diagnostic procedures, and
does not induce a significant risk in this population with cancer that was
treated with high dose radiotherapy. Further patient burden involves one extra
visit to the hospital of one hour, and one intravenous injection for
administration of the tracer.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Patients with HNSCC, who were treated 6-12 months ago with (CC)RT of one neck side with curative intent, and who received variable doses to the major salivary glands at the irradiated side with at least one gland receiving a significant part >36Gy EQD2.
Exclusion criteria
Pregnancy, lactation, inability to provide informed consent
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 | NL58445.031.16 |