In this study we will investigate whether there is a difference in PSMA expression between BM and RN by:1. Evaluating PSMA expression using Ga68-PSMA PET/CT in BM of NSCLC, melanoma and breastcancer patients eligible for SRT or surgery.2. Evaluating…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For group 1, 2 and 7 the sensitivity (ability of the test to correctly identify
those patients with the disease) of the Ga68-PSMA brain imaging will be
determined.
For group 3, 4 and 8 the specificity (the ability of the test to correctly
diagnose those patients without the disease) of the Ga68-PSMA brain imaging
will be determined.
In case the study for research question 1 shows Ga68-PSMA uptake in 70% of the
cases, we can continue studying research question 2.
In case there is no or a low Ga68-PSMA uptake in the patients with RN (research
question 2), we will continue with the study in patients with irradiated BM, in
whom there is a true dilemma whether there is RN or tumor progression (research
question 3).
For group 5, 6 and 9, the sensitivity and specificity will be determined.
In case Ga68-PSMA brain imaging can diagnose in RN vs tumor progression in 7 of
10 patients (per tumor type) in a correct way, a future clinical diagnostic
study with higher patient numbers will be initiated.
Secondary outcome
na
Background summary
After SRT, the national guidelines advise to execute a 3- monthly MRI-brain
evaluation to screen for recurrent (local and/or distant) BM. During MRI
follow-up, irradiated lesions can increase in size or edema, which could be due
to either radiation necrosis (RN) or tumor progression.
With the original MRI sequences (T1 -/+ contrast, T2 and diffusion), and 18-FDG
PET CT imaging, it is not possible to make a reliable distinction between RN
and tumor progression. Reliable distinction is important for correctly
initiating new tumor therapy. Ga68-PSMA tracer is a novel PET tracer and has
high potential in reliably differentiate between RN and tumor progression.
Study objective
In this study we will investigate whether there is a difference in PSMA
expression between BM and RN by:
1. Evaluating PSMA expression using Ga68-PSMA PET/CT in BM of NSCLC, melanoma
and breastcancer patients eligible for SRT or surgery.
2. Evaluating PSMA expression using Ga68-PSMA PET/CT in patients with definite
RN.
3. Evaluating the use of Ga68-PSMA PET/CT to differentiate progressive BM of
NSCLC, melanoma or breastcancer from radiation necrosis by quantifying PSMA.
Study design
a diagnostic feasibility study
Study burden and risks
The burden and risks associated with participation are considered low. After
SRT, MRI of the brain are part of the routine diagnostic follow up. Use of
positron emitting radionuclides means exposure to ionizing radiation. The
radiation exposure will be 2,0 mSv in total per patient. Extra time for the
patient is 90 minutes for the PET CT scan. The long term risk of developing a
secondary malignancy due to radiation exposure is theorethical, because of the
limited life expectancy of patients with BM in NSCLC, melanoma and
breastcancer. Since there is a lack of a reliable diagnostic imaging for
differentiation between RN and tumorprogression, the results of this study can
be of high interest for BM patients, in whom during follow up the diagnostic
dilemma occurs.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
For group 1, 2 and 7: - newly diagnosed BM from either NSCLC (group 1),
melanoma (group 2) and breast cancer (group 7) For group 3, 4 and 8: - Brain
lesion at the location of a formerly BM that has been treated with SRT (> 9
months ago), with the definite diagnosis of RN at the location of formerly
SRT-treated BM of NSCLC (group 3), melanoma (group 4) and breast cancer (group
8). For group 5, 6 and 9: - Brain lesion at the location of a formerly BM in
which the diagnostic dilemma of RN and recurrent BM of NSCLC (group 5),
melanoma (group 6) or breast cancer (group 9).
Exclusion criteria
For all groups: - Allergy to Ga68-PSMA - Epileptic seizure < 7 days before
Ga68-PSMA PET/CT scan - Life expectancy less than 3 months - Patients with
prostate carcinoma
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 | NL66822.031.19 |