The goal of this study is to visualize and quantify the somatostatin receptor expression and occupancy directly before and after the injection of long-acting lanreotide in NET patients by imaging with [68Ga]-DOTATATE PET.
ID
Source
Brief title
Condition
- Endocrine neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To visualize and quantify the difference in somatostatin receptor occupancy
directly before and after lanreotide injection.
Secondary outcome
a. To assess a correlation between tumor [68Ga]-DOTATATE uptake and size in
relation to lanreotide binding.
b. To assess differences in [Ga68]-DOTATATE uptake and behavior (reaction to
lanreotide) between different metastasis in 1 patient.
c. To assess the differences in uptake in normal tissue (thyroid, spleen, liver
etc.) before and after lanreotide.
d. To assess the correlation between clinical symptoms, receptor occupancy, and
tumor markers.
Background summary
Patients with NETs who are treated with long-acting lanreotide can experience
an increase in clinical symptoms and/or tumor markers while on treatment. The
reason(s) behind somatostatin analogue tachyphylaxis and resistance are not yet
fully understood, but different methods have been proposed, such as receptor
down-regulation or desensitization, or an increased expression of other
(non-targeted) receptor subtypes, or mutation of the receptor. Knowledge about
receptor occupancy will also become more important when lanreotide (and other
somatostatin analogues) is not only used for the treatment of carcinoid
symptoms but also as anti-proliferative treatment.
Study objective
The goal of this study is to visualize and quantify the somatostatin receptor
expression and occupancy directly before and after the injection of long-acting
lanreotide in NET patients by imaging with [68Ga]-DOTATATE PET.
Study design
Patients with a NET that are treated with lanreotide and are scheduled for a
[68Ga]-DOTATATE PET/CT scan the day before lanreotide treatment, will be
approached for a second [68Ga]-DOTATATE PET/CT scan the day after lanreotide
treatment. Clinical decision-making will be based on the first scan, the second
scan is additional and for research purposes only.
A schedule for one patient is as follows:
Day 1: [68Ga]-DOTATATE PET/CT scan as planned
Day 2: Lanreotide injection as planned
Day 3: Additional [68Ga]-DOTATATE PET/CT scan
All sequential scans will be compared by a nuclear medicine physician (blinded)
for differences in biodistribution. Furthermore, all scans will be quantified
by using a standard software package and expressed in a standardized uptake
value (SUV) and tumor to background ratio. The uptake (SUV) will be measured in
all lesions visualized on either one of the PET-scans and compared with each
other.
Study burden and risks
Patients are asked to undergo 1 extra PET scan for this study. The burden of
this is one extra hospital visit of approximately 1.5 hours. There are no known
side-effects of [Ga68]-DOTATATE PET.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Age
Inclusion criteria
- >=18 years old
- Histologically confirmed low and intermediate grade NET
- Metastatic or unresectable disease
- Measurable disease on [68Ga]-DOTATATE PET-scan
- WHO performance status less than 2
- Life expectancy more than 3 months
- Long-acting lanreotide treatment for at least 4 months
Exclusion criteria
- Pregnant or breast-feeding
- Claustrophobic
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 | NL45948.031.13 |