Metastatic Breast CancerIMPACT-MBCNCT01957332
IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer
A study testing Molecular imaging in people with Metastatic Breast Cancer, run by University Medical Center Groningen at 3 sites in Netherlands.
Trial summary
Current patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. 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?
- Molecular imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 3 sitesNetherlands
- Study dates
- 30 Aug 2013to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy.
- Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation which may include:
- no recent (< 2 weeks prior to screening visit) significant worsening of MBC related signs and symptoms according to patient history.
- in case of liver metastases: no significant increase in liver function tests alanine aminotransferase aspartate transaminase (ASAT) and alanine transaminase (ALAT) in 2 weeks prior to screening visit. (Significant increase of liver function test is defined as 50% increase of absolute amount of ASAT/ALAT.)
- Patients in whom standard imaging work-up of MBC was recently (≤ 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F-FDG-PET and bone scintigraphy.
- Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
Show all 12Show fewer
- Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
- Primary tumor blocks available for confirmatory central laboratory ER/HER2 testing in the UMCG. If available a snap frozen sample of the primary tumor will also be centralized in the University Medical Center Groningen (UMCG).
- WHO performance status 0-2.
- Patient is able to undergo PET imaging procedures.
- Age >18 years of age, willing and able to comply with the protocol as judged by the investigator.
- Signed written informed consent.
Who cannot join
- Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history.
- Pregnant or lactating women.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- Inability to comply with study procedures.
- Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
VU University Medical Center
Amsterdam
University Medical Center
Groningen, 9700RB
University Medical Center St. Radboud
Nijmegen
About this study
Official title: Towards Patient Tailored Cancer Treatment Supported by Molecular Imaging IMPACT: IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer
Current patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion of the tumor is found quite frequently and molecular heterogeneity can occur within one patient, up-to-date whole body information is necessary to determine estrogen receptor (ER) and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide therapy decision. With molecular imaging via PET this information can be obtained in a non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular characterization of one metastasis at the beginning and, if feasible, of an additional biopsy during therapy, is necessary.
Read the detailed description
Patient selection for hormone therapy and anti-HER2 therapy is based on the presence of their respective targets, the ER and HER2, as currently assessed on tumor tissue by molecular biological techniques. In primary breast cancer, both ER and HER2 are powerful predictors for response to ER or HER2 targeting treatment, driving treatment decisions. If both receptors are absent, targeted hormone or anti-HER2 therapy will not be administered and chemotherapy is the only therapeutic option left. MBC management in oncology practice is often based on ER and HER2 status of the primary tumor. However, a biopsy of a metastasis is considered part of the standard work up for MBC, in view of the potential conversion of ER and HER2 during the course of the disease. In contrast to primary breast cancer, no prospective studies have been done to evaluate the impact of (converted) receptor status on metastases, on prognosis and prediction of response to subsequent targeted therapy. Although receptor conversion in MBC is a well known phenomenon, clinicians may refrain from having a biopsy taken, for instance when it would require a highly invasive procedure. Even if it is feasible, the biopsy will only reflect ER and HER2 status of a single lesion, and disregard the potential heterogeneity of expression of ER and HER2 status between and within metastatic lesions.
Therefore, the current standard work up of MBC is not adequate enough or too invasive in a relevant proportion of MBC patients to drive treatment decisions. As a result, these patients incorrectly receive an ineffective treatment with potentially toxic effects. Meanwhile, an effective treatment for these patients may be delayed or even denied (such as chemotherapy or anti-HER2 based therapy) because of inadequate assessment of ER and HER2 status. This shows the need of obtaining up-to-date whole body information with information of characteristics of the different metastases within a patient. Non-invasive 18F-fluoroestradiol(18F-FES)-PET and Zirconium-89(89Zr)-trastuzumab-PET scan techniques are able to visualize the ER and HER2 in metastatic lesions throughout the whole body, and may therefore - in a patient friendly way- provide comprehensive information (i.e. of the primary tumor and various metastatic lesions) on ER and HER2 status. Furthermore, optimal selection of the right treatment for the right patient may not only reduce unnecessary toxicity, but also health care costs. Although various studies have already indicated the clinical utility of 18F-FES-PET and 89Zr-trastuzumab-PET, no prospective data are yet available assessing their predictive value (14-19). Therefore, it is clear that these new techniques, and also the aspects of cost-effectiveness, need to be prospectively evaluated within the framework of established assessments (including metastases biopsies and FDG-PET), to ensure their implementation in standard care.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Molecular imaging
- Keywords
- molecular imaging, HER2-PET, 89Zr-trastuzumab, FES-PET, metastatic breast cancer, clinical utility
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular imagingProcedure or surgery
Also called HER2-PET, Injection of 89Zr-trastuzumab followed by PET scan
On the day of FES-injection\&scan or the day after FES-injection, 89Zr-trastuzumab (~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection.
Molecular imagingProcedure or surgery
Also called FES injection, Injection of 18F-FES followed by PET scan
All patients receive 18F-FES (~200MBq) injection followed by a FES-PET.
| Study group | Role | What they receive |
|---|---|---|
| Molecular imaging | Experimental | All patients receive 18F-FES (~200MBq) injection followed by a FES-PET. On the same day or the day after 18F-FES injection 89Zr-trastuzumab (~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection. Receives: Procedure: Molecular imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical utility
The primary objective is to evaluate the clinical utility of experimental PET scans, in the setting of MBC at first presentation. These scans include Fluor-18-16 alpha-fluoroestradiol(18F-FES)-PET and Zirconium-89(89Zr)-trastuzumab-PET scans at baseline, and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG)-PET for early response measurement. Clinical utility in this setting might be defined as improved personalized medicine, when the PET scans show improved predictive value for therapy response in comparison or in addition to currently available clinical information including a biopsy. But also when the PET scans would have the same predictive value for therapy response compared to a biopsy, they would have clinical utility because they are less invasive and more patient friendly. The inherent focus (the primary endpoint) of this study is therefore therapy response. Therapy response will be related to the novel PET scans, both per patient and per metastasis analysis.
Measured: 3-5 years (End of study)
Secondary outcomes (9)
Correlation PET scans & progression-free survival (PFS)
To relate experimental PET scans (baseline 18F-FES-PET and 89Zr-trastuzumab-PET; 2 week 18F-FDG-PET scan) to (progression free) survival.
Measured: 3-5 years (End of study)
Correlation of DNA and RNA analyses to imaging, molecular analyses and follow-up data
To relate DNA sequencing and RNA expression analysis of the baseline biopsy and venous blood samples (only DNA sequencing; baseline) to all other molecular, imaging (standard and experimental), and clinical follow-up data (treatment response and survival).
Measured: 3-5 years (End of study)
Correlation miRNA analysis to molecular analyses, imaging & clincal follow-up data
To relate miRNA analysis of the baseline biopsy and a venous blood sample at baseline to all other molecular, imaging and clinical follow-up data.
Measured: 3-5 years (End of study)
Correlation of peptide profiling to all other molecular, imaging and clinical follow-up data
To relate peptide profiling of new baseline biopsy and venous blood samples (baseline and day of standard response assessment) to all other molecular, imaging and clinical follow-up data.
Measured: 3-5 years (EoS)
Correlation of standard pathology results to all molecular, imaging and clinical follow up data.
To assess molecular changes (including pathological examination) of primary biopsy, new baseline biopsy and (optional) biopsy taken during treatment and relate to all molecular, imaging and clinical follow up data.
Measured: 3-5 years (EoS)
To compare CTC enrichment approaches and correlation of CTC analysis to all molecular, imaging and clinical follow-up data
To relate CTC count and ER/HER2 status of CTCs at baseline to all molecular, imaging and clinical follow-up data.
Measured: 3-5 years (EoS)
Correlation circulating tumor DNA analysis to all other molecular, imaging and clinical follow-up data
To relate circulating tumor DNA analysis (baseline, day of early 18F-FDG-PET imaging and day of standard response assessment) to all other molecular, imaging and clinical follow-up data.
Measured: 3-5 years (EoS)
Cost-effectiveness of molecular imaging
To assess cost-effectiveness of experimental PET scans.
Measured: 3-5 years (EoS)
QoL
To assess impact of baseline biopsy procedure and baseline molecular imaging, as well as quality of Life (QoL) before and during therapy.
Measured: 3-5 years (EoS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start30 Aug 2013
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, University Medical Center Nijmegen
- Responsible party
- Principal investigator, C.P. Schroder, University Medical Center Groningen
- Investigators
- Carolien Schröder, MD, PhD, Principal investigator, University Medical Center GroningenWillemien Menke, MD, PhD, Principal investigator, VUMCWinette vd Graaf, MD, PhD, Principal investigator, RUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957332
- Sponsor's protocol ID
- IMPACT MBC
- Acronym
- IMPACT-MBC
- Status last verified
- Nov 2024
- First submitted
- 3 Sep 2013
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Geel JJL, Eisses B, Elias SG, Brouwers AH, Bensch F, Gerritse SL, Angus L, Glaudemans AWJM, Kuip EJM, Jager A, Oprea-Lager DE, Vugts DJ, Emmering J, Arens AIJ, Oyen WJG, van der Vegt B, Lub-de Hooge MN, Menke-van der Houven van Oord CW, de Vries EGE, Schroder CP; IMPACT-Metastatic Breast Cancer Consortium. 18F-Fluorodeoxyglucose Positron Emission Tomography for Estimating Outcomes After Initial Treatment for Metastatic Breast Cancer: A Nonrandomized Clinical Cohort Trial. JAMA Oncol. 2026 Jun 1;12(6):611-618. doi: 10.1001/jamaoncol.2026.0767.
PubMed 41989806van Geel JJL, Moustaquim J, Boers J, Elias SG, Smeets EMM, Knip JJ, Glaudemans AWJM, de Vries EFJ, Hospers GAP, van Kruchten M, Stokkel M, Oprea-Lager DE, Menke-van der Houven van Oordt WC, de Vries EGE, Schroder CP; IMPACT-Metastatic Breast Consortium. Intrapatient 16alpha-[18F]Fluoro-17beta-Estradiol PET Heterogeneity as a Prognostic Factor for Endocrine Therapy Response and Survival in Patients with Estrogen Receptor-Positive Metastatic Breast Cancer. J Nucl Med. 2025 Feb 3;66(2):194-200. doi: 10.2967/jnumed.124.268984.
PubMed 39848768Boers J, Eisses B, Zwager MC, van Geel JJL, Bensch F, de Vries EFJ, Hospers GAP, Glaudemans AWJM, Brouwers AH, den Dekker MAM, Elias SG, Kuip EJM, van Herpen CML, Jager A, van der Veldt AAM, Oprea-Lager DE, de Vries EGE, van der Vegt B, Menke-van der Houven van Oordt WC, Schroder CP; IMPACT-Metastatic Breast Consortium. Correlation between Histopathological Prognostic Tumor Characteristics and [18F]FDG Uptake in Corresponding Metastases in Newly Diagnosed Metastatic Breast Cancer. Diagnostics (Basel). 2024 Feb 14;14(4):416. doi: 10.3390/diagnostics14040416.
PubMed 38396455van Geel JJL, Boers J, Elias SG, Glaudemans AWJM, de Vries EFJ, Hospers GAP, van Kruchten M, Kuip EJM, Jager A, Menke-van der Houven van Oordt WC, van der Vegt B, de Vries EGE, Schroder CP; IMPACT-Metastatic Breast Consortium. Clinical Validity of 16alpha-[18F]Fluoro-17beta-Estradiol Positron Emission Tomography/Computed Tomography to Assess Estrogen Receptor Status in Newly Diagnosed Metastatic Breast Cancer. J Clin Oncol. 2022 Nov 1;40(31):3642-3652. doi: 10.1200/JCO.22.00400. Epub 2022 May 18.
PubMed 35584346
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards Patient Tailored Cancer Treatment Supported by Molecular Imaging IMPACT: IMaging PAtients for Cancer Drug selecTion - Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT01957332
- Acronym / sponsor ID
- IMPACT-MBC / IMPACT MBC
- Conditions
- Metastatic Breast Cancer
- Keywords
- molecular imaging, HER2-PET, 89Zr-trastuzumab, FES-PET, metastatic breast cancer, clinical utility
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Amsterdam UMC, location VUmc, University Medical Center Nijmegen
- Study start
- 30 Aug 2013 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current patient work-up, including conventional imaging and pathological assessment of just one single biopsy, might be insufficient to identify metastatic breast cancer patients, who possibly benefit from first-line anti-hormonal or anti-HER2 therapy. As receptor conversion of the tumor is found quite frequently and molecular heterogeneity can occur within one patient, up-to-date whole body information is necessary to determine estrogen receptor (ER) and/or human epidermal growth factor receptor 2 (HER2) receptor status and subsequently guide therapy decision. With molecular imaging via PET this information can be obtained in a non-invasive, patient friendly way. Furthermore, to improve and individualize treatment and be able to identify (new) drug targets and biomarkers, sampling of venous blood, circulating tumor cells (CTC), as well as circulating tumor DNA, microRNA (miRNA) and molecular characterization of one metastasis at the beginning and, if feasible, of an additional biopsy during therapy, is necessary.
Detailed description
Patient selection for hormone therapy and anti-HER2 therapy is based on the presence of their respective targets, the ER and HER2, as currently assessed on tumor tissue by molecular biological techniques. In primary breast cancer, both ER and HER2 are powerful predictors for response to ER or HER2 targeting treatment, driving treatment decisions. If both receptors are absent, targeted hormone or anti-HER2 therapy will not be administered and chemotherapy is the only therapeutic option left. MBC management in oncology practice is often based on ER and HER2 status of the primary tumor. However, a biopsy of a metastasis is considered part of the standard work up for MBC, in view of the potential conversion of ER and HER2 during the course of the disease. In contrast to primary breast cancer, no prospective studies have been done to evaluate the impact of (converted) receptor status on metastases, on prognosis and prediction of response to subsequent targeted therapy. Although receptor conversion in MBC is a well known phenomenon, clinicians may refrain from having a biopsy taken, for instance when it would require a highly invasive procedure. Even if it is feasible, the biopsy will only reflect ER and HER2 status of a single lesion, and disregard the potential heterogeneity of expression of ER and HER2 status between and within metastatic lesions.
Therefore, the current standard work up of MBC is not adequate enough or too invasive in a relevant proportion of MBC patients to drive treatment decisions. As a result, these patients incorrectly receive an ineffective treatment with potentially toxic effects. Meanwhile, an effective treatment for these patients may be delayed or even denied (such as chemotherapy or anti-HER2 based therapy) because of inadequate assessment of ER and HER2 status. This shows the need of obtaining up-to-date whole body information with information of characteristics of the different metastases within a patient. Non-invasive 18F-fluoroestradiol(18F-FES)-PET and Zirconium-89(89Zr)-trastuzumab-PET scan techniques are able to visualize the ER and HER2 in metastatic lesions throughout the whole body, and may therefore - in a patient friendly way- provide comprehensive information (i.e. of the primary tumor and various metastatic lesions) on ER and HER2 status. Furthermore, optimal selection of the right treatment for the right patient may not only reduce unnecessary toxicity, but also health care costs. Although various studies have already indicated the clinical utility of 18F-FES-PET and 89Zr-trastuzumab-PET, no prospective data are yet available assessing their predictive value (14-19). Therefore, it is clear that these new techniques, and also the aspects of cost-effectiveness, need to be prospectively evaluated within the framework of established assessments (including metastases biopsies and FDG-PET), to ensure their implementation in standard care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Molecular imaging | Experimental | Procedure: Molecular imagingAll patients receive 18F-FES (~200MBq) injection followed by a FES-PET. On the same day or the day after 18F-FES injection 89Zr-trastuzumab (~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy.
- Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation which may include:
- Patients in whom standard imaging work-up of MBC was recently (≤ 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F-FDG-PET and bone scintigraphy.
- Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
- Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
Key exclusion criteria (5 listed)
- Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history.
- Pregnant or lactating women.
- Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
- Inability to comply with study procedures.
- Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular imagingAlso: HER2-PET, Injection of 89Zr-trastuzumab followed by PET scanOn the day of FES-injection\&scan or the day after FES-injection, 89Zr-trastuzumab (~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection. | Procedure or surgery | Molecular imaging |
| Molecular imagingAlso: FES injection, Injection of 18F-FES followed by PET scanAll patients receive 18F-FES (~200MBq) injection followed by a FES-PET. | Procedure or surgery | Molecular imaging |
Primary outcome
Clinical utility
Time frame: 3-5 years (End of study)
The primary objective is to evaluate the clinical utility of experimental PET scans, in the setting of MBC at first presentation. These scans include Fluor-18-16 alpha-fluoroestradiol(18F-FES)-PET and Zirconium-89(89Zr)-trastuzumab-PET scans at baseline, and 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose(18F-FDG)-PET for early response measurement. Clinical utility in this setting might be defined as improved personalized medicine, when the PET scans show improved predictive value for therapy response in comparison or in addition to currently available clinical information including a biopsy. But also when the PET scans would have the same predictive value for therapy response compared to a biopsy, they would have clinical utility because they are less invasive and more patient friendly. The inherent focus (the primary endpoint) of this study is therefore therapy response. Therapy response will be related to the novel PET scans, both per patient and per metastasis analysis.
9 secondary outcomes
Correlation PET scans & progression-free survival (PFS)
Time frame: 3-5 years (End of study)
Correlation of DNA and RNA analyses to imaging, molecular analyses and follow-up data
Time frame: 3-5 years (End of study)
Correlation miRNA analysis to molecular analyses, imaging & clincal follow-up data
Time frame: 3-5 years (End of study)
Correlation of peptide profiling to all other molecular, imaging and clinical follow-up data
Time frame: 3-5 years (EoS)
Correlation of standard pathology results to all molecular, imaging and clinical follow up data.
Time frame: 3-5 years (EoS)
To compare CTC enrichment approaches and correlation of CTC analysis to all molecular, imaging and clinical follow-up data
Time frame: 3-5 years (EoS)
Correlation circulating tumor DNA analysis to all other molecular, imaging and clinical follow-up data
Time frame: 3-5 years (EoS)
Cost-effectiveness of molecular imaging
Time frame: 3-5 years (EoS)
QoL
Time frame: 3-5 years (EoS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 41989806van Geel JJL, Eisses B, Elias SG, Brouwers AH, Bensch F, Gerritse SL, Angus L, Glaudemans AWJM, Kuip EJM, Jager A, Oprea-Lager DE, Vugts DJ, Emmering J, Arens AIJ, Oyen WJG, van der Vegt B, Lub-de Hooge MN, Menke-van der Houven van Oord CW, de Vries EGE, Schroder CP; IMPACT-Metastatic Breast Cancer Consortium. 18F-Fluorodeoxyglucose Positron Emission Tomography for Estimating Outcomes After Initial Treatment for Metastatic Breast Cancer: A Nonrandomized Clinical Cohort Trial. JAMA Oncol. 2026 Jun 1;12(6):611-618. doi: 10.1001/jamaoncol.2026.0767.
- Derived from this study: PubMed 39848768van Geel JJL, Moustaquim J, Boers J, Elias SG, Smeets EMM, Knip JJ, Glaudemans AWJM, de Vries EFJ, Hospers GAP, van Kruchten M, Stokkel M, Oprea-Lager DE, Menke-van der Houven van Oordt WC, de Vries EGE, Schroder CP; IMPACT-Metastatic Breast Consortium. Intrapatient 16alpha-[18F]Fluoro-17beta-Estradiol PET Heterogeneity as a Prognostic Factor for Endocrine Therapy Response and Survival in Patients with Estrogen Receptor-Positive Metastatic Breast Cancer. J Nucl Med. 2025 Feb 3;66(2):194-200. doi: 10.2967/jnumed.124.268984.
- Derived from this study: PubMed 38396455Boers J, Eisses B, Zwager MC, van Geel JJL, Bensch F, de Vries EFJ, Hospers GAP, Glaudemans AWJM, Brouwers AH, den Dekker MAM, Elias SG, Kuip EJM, van Herpen CML, Jager A, van der Veldt AAM, Oprea-Lager DE, de Vries EGE, van der Vegt B, Menke-van der Houven van Oordt WC, Schroder CP; IMPACT-Metastatic Breast Consortium. Correlation between Histopathological Prognostic Tumor Characteristics and [18F]FDG Uptake in Corresponding Metastases in Newly Diagnosed Metastatic Breast Cancer. Diagnostics (Basel). 2024 Feb 14;14(4):416. doi: 10.3390/diagnostics14040416.
- Derived from this study: PubMed 35584346van Geel JJL, Boers J, Elias SG, Glaudemans AWJM, de Vries EFJ, Hospers GAP, van Kruchten M, Kuip EJM, Jager A, Menke-van der Houven van Oordt WC, van der Vegt B, de Vries EGE, Schroder CP; IMPACT-Metastatic Breast Consortium. Clinical Validity of 16alpha-[18F]Fluoro-17beta-Estradiol Positron Emission Tomography/Computed Tomography to Assess Estrogen Receptor Status in Newly Diagnosed Metastatic Breast Cancer. J Clin Oncol. 2022 Nov 1;40(31):3642-3652. doi: 10.1200/JCO.22.00400. Epub 2022 May 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolien Schröder, MD, PhD principal investigator
University Medical Center Groningen
Willemien Menke, MD, PhD principal investigator
VUMC
Winette vd Graaf, MD, PhD principal investigator
RUMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Molecular imaging in people with Metastatic Breast Cancer, run by University Medical Center Groningen at 3 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 12 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Clinical utility (time frame: 3-5 years (End of study)). 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 NCT01957332, which also lists 4 linked publications.
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 20 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.