The aim of this study is to evaluate androgen receptor (AR) and estrogen receptor (ER) expression non-invasively by means of PET imaging with the tracers 18F-FDHT and 18F-FES. To verify the PET results, the standard diagnostic biopsy will be…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The sensitivity and specificity of FDHT PET and FES PET to visualize and
quantify AR- and ER-expression respectively, when compared to
imunnohistochemistry on the biopsied metastasis.
Secondary outcome
- the heterogeneity of FDHT and FES uptake among metastases within an
individual patient, as well as the inter-patient differences.
- interobserver variation in PET interpretation between two independent
observers from both study sites (VUMC and UMCG)
Background summary
Patients with breast cancer can nowadays be treated with endocrine therapy when
the tumor is sensitive to estrogens (which is in case of estrogen receptor [ER]
positive disease. It is known that tumor ER status can change during disease
progression and up to 30% of the metastases show discordant ER-expression
compared to the primary tumor. For this reason, several guidelines now
recommand to perform a biopsy of a metastasis to re-evaluate ER status (among
others). It is however not always possible to perform a biopsy due to patient
factors or the location of the lesion. Moreover, a biopsy only provides
information of a single lesion and may not always be representative for the
overall ER status of the patient's disease. For this reason, it would be
valuable to obtain information about tumor endocrine sensitivity by
non-invasive measurements like positron emission tomography (PET) imaging.
Study objective
The aim of this study is to evaluate androgen receptor (AR) and estrogen
receptor (ER) expression non-invasively by means of PET imaging with the
tracers 18F-FDHT and 18F-FES. To verify the PET results, the standard
diagnostic biopsy will be performed as well as a CT-scan and bone scan.
Study design
Patients will undergo two experimental procedures: the FES-PET scan to image
ER-expresion; and the FDHT-PET scan to image AR-expression.
Within a 6-8 week timeframe other (standard) diagnostics will also be performed
(CT-scan, bone scan and tumor biopsy).
Intervention
PET scan (twice)
Study burden and risks
The radiation burden for the patient is ~11 mSv
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
1. Metastatic breast cancer, with at least one known metastasis outside of the liver
2. Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
3. Postmenopausal status defined as one of the following:
a. age >=60 years
b. previous bilateral oophorectomy
c. age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
d. patients age <60 years using an ER-antagonist should have amenorrhea for > 12 months and FSH >24 U/L and LH >14 U/L
e. patient age <60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures
4. Initially ER-positive tumor histology.
5. ECOG performance status 0-2.
6. Signed written informed consent
7. Able to comply with the protocol
Exclusion criteria
1. Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
2. Life-expectancy <= 3 months
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 | EUCTR2012-003981-42-NL |
| CCMO | NL41954.042.12 |