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Metastatic Breast CancerPhase 2NCT01988324

AR and ER Imaging in Metastatic Breast Cancer

A Phase 2 study testing FDHT-PET scan, FES-PET scan and CT-scan in people with Metastatic Breast Cancer, run by University Medical Center Groningen at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
FDHT-PET scan, FES-PET scan and CT-scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesNetherlands
Study dates
Aug 2014to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic breast cancer, with at least one known metastasis outside of the liver
  • Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
  • Postmenopausal status defined as one of the following:
  • age ≥60 years
  • previous bilateral oophorectomy
  • age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
Show all 11Show fewer
  • 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
  • Initially ER-positive tumor histology.
  • ECOG performance status 0-2.
  • Signed written informed consent
  • Able to comply with the protocol

Who cannot join

  • Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
  • Life-expectancy ≤ 3 months

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • VU Medical Center

    Amsterdam

  • University Medical Center Groningen

    Groningen

Other trials in Netherlands

About this study

Official title: Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients

Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular imaging of tumor AR- and ER-expression may well be of value for future treatment decision-making.

Being tested
FDHT-PET scan, FES-PET scan, CT-scan, Bone scintigraphy, Tumor biopsy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FDHT-PET scanOther

  • FES-PET scanOther

  • CT-scanOther

  • Bone scintigraphyOther

  • Tumor biopsyOther

Study groups in NCT01988324
Study groupRoleWhat they receive
FES/FDHT-PETExperimentalNot described
Receives: Other: FDHT-PET scan; Other: FES-PET scan; Other: CT-scan; Other: Bone scintigraphy; Other: Tumor biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity/ specificity

    The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated.

    Measured: within two months

Secondary outcomes (3)

  1. Accuracy

    The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.

    Measured: within six weeks

  2. Inter- and intra-patient variation

    Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.

    Measured: within six weeks

  3. Inter-observer variation

    Inter-observer variation in FES PET and FDHT PET results in two independent observers.

    Measured: approximately two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2013 (estimated)
  2. Study startAug 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01988324
Sponsor's protocol ID
2012.2708
Status last verified
May 2024
First submitted
1 Nov 2013
Last updated
6 May 2024
Results posted
No

Publications

  • Mammatas LH, Venema CM, Schroder CP, de Vet HCW, van Kruchten M, Glaudemans AWJM, Yaqub MM, Verheul HMW, Boven E, van der Vegt B, de Vries EFJ, de Vries EGE, Hoekstra OS, Hospers GAP, der Houven van Oordt CWM. Visual and quantitative evaluation of [18F]FES and [18F]FDHT PET in patients with metastatic breast cancer: an interobserver variability study. EJNMMI Res. 2020 Apr 19;10(1):40. doi: 10.1186/s13550-020-00627-z.

    PubMed 32307594

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FDHT-PET scan, FES-PET scan and CT-scan in people with Metastatic Breast Cancer, run by University Medical Center Groningen at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity/ specificity (time frame: within two months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01988324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.

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