Metastatic Breast CancerRESPECTNCT03266744
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study
A study testing Computerised Tomography, Whole Body Magnetic Resonance Imaging and Bone scan in people with Metastatic Breast Cancer, run by East and North Hertfordshire NHS Trust.
Trial summary
This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Computerised Tomography, Whole Body Magnetic Resonance Imaging and Bone scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 21 Apr 2016to May 2018
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological diagnosis of breast cancer
- Single or multiple bone metastases (no extraosseous or non-bony metastatic disease permitted)
- Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
- Aged 18 and over
- Life expectancy of over 6 months
- No current active malignancy other than breast cancer
- Written informed consent must be given according to GCP, and national/local regulations
Who cannot join
- Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
- Absolute contraindication to MRI studies, CT scans or bone scans
- Pregnancy
- Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient before registration in the trial before patient registration.
About this study
This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment.
Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.
Read the detailed description
Patients are eligible for RESPECT if they have bone-only metastatic breast cancer (MBC), as established by standard CT and bone scintigraphy, and are starting a new line of systemic therapy. This can be first line SACT or any subsequent line.
All patients undergo a baseline CT scan (thorax/abdomen/pelvis) and isotope bone scan prior to commencing their new systemic therapy. All CT and bone scans are performed according to standard departmental protocols, with no deviations required. WB-MRI are performed within 2 weeks of study entry. CT scans and WB-MRI are then performed every 12 weeks until week 96, and then every 24 weeks until the patient completes the study. The reporting radiologist who interprets the CT scans is blinded to the images and results of the WB-MRI scan and vice versa.
At study commencement Participants are required to have had a CT scan of the thorax, abdomen and pelvis and a bone scan (bone scintigraphy with technetium-99m-methylene diphosphonate) no more than 4 weeks prior to trial entry to ensure that they have bony-only metastatic disease, as defined using standard imaging. Baseline WB-MRI scans are performed within 2 weeks of entry into the study.
Participants are assessed in clinic and a baseline physical examination is undertaken. Any additional tests required for the initiation of the new SACT are performed at the discretion of the treating clinician and according to local protocols.
During the study CT scans and WB-MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in the study protocol). Scans are performed within the range of 7 days prior and 7 days after the planned 12 weekly scan interval date.
If there is evidence of equivocal disease progression on WB-MRI only, a repeat WB-MRI is undertaken between 28 and 42 days after the equivocal WB-MRI to confirm or refute the presence of progressive disease. If this confirmed disease progression, then the date of progression is defined as that of the original WB-MRI (i.e. the one performed 4-6 weeks earlier). No repeat CT scans are performed alongside the confirmatory WB-MRI.
Participants are reviewed in outpatient clinic after every imaging time point so that the results of the CT and WB-MRI can be relayed to them by their oncologist and a decision can be made about their ongoing treatment. If more frequent clinic reviews are required then these are not prohibited by the trial protocol. As with the frequency of imaging, the required trial clinic visits change to every 24 weeks after the week 96 visit. During these clinic visits a clinical assessment is made and a full physical examination undertaken. Current anti-cancer drug therapy, including any changes, are documented. Any skeletal related events are also documented. Skeletal related events are defined within the RESPECT study as:
- pathological fracture
- metastatic spinal cord compression
- radiotherapy for bone pain
- surgery to site of bone metastasis Case report forms are completed by the trial administrators at every imaging time point. These are referred to as week 12, week 24, week 36 and so forth.
Patient Imaging Questionnaires are performed at the week 12 and week 36 visits, and are completed by the patients within the radiology department soon after their CT and WB-MRI scans has been performed.
End of study
The end of the study protocol is reached when any of the following occur:
- Progressive bone and/or visceral disease is demonstrated on CT scan and WB-MRI (as defined in section X).
- Unequivocal progressive bone and/or visceral disease is demonstrated on WB-MRI alone (as defined in section X).
- CT and/or WB-MRI findings requiring intervention such as palliative radiotherapy, or a change in systemic therapy.
- Equivocal evidence of progressive bone and/or visceral disease (not meeting the full criteria for disease progression in section 7.1.3) demonstrated on WB-MRI only, with confirmation of findings on repeat WB-MRI undertaken 4-6 weeks later.
- Symptomatic skeletal disease or evidence of clinical progression of disease that necessitates a change in systemic therapy.
A repeat nuclear medicine bone scan is undertaken once the participant met one of the end of study criteria above.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Computerised Tomography, Whole Body Magnetic Resonance Imaging, Bone scan
- Keywords
- Metastatic Breast Cancer, Whole Body MRI, Computerised Tomography, Bone scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerised TomographyDiagnostic test
Whole Body Magnetic Resonance ImagingDiagnostic test
Bone scanDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Main study group | Other | Patients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed.
At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI. Receives: Diagnostic Test: Computerised Tomography; Diagnostic Test: Whole Body Magnetic Resonance Imaging; Diagnostic Test: Bone scan |
| WB-MRI sub-study group | Other | Patients will be given the opportunity to participate in a sub-study of WB-MRI reproducibility. This involves a repeat scan of the Whole Body Magnetic Resonance Imaging (WB-MRI) diffusion-weighted sequences. This will be shorter in duration than the full WB-MRI scan and will take place within one hour of completing the full WB-MRI scan. Receives: Diagnostic Test: Whole Body Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression on CT and/or WB-MRI
Description of the metric used to characterize the specific primary outcome measure, if not included in the primary outcome measure title.
Measured: Up to 96 weeks (from date of consent until the date of first documented progression)
Secondary outcomes (1)
Disease progression on CT and/or WB-MRI
Time point(s) at which the measurement is assessed for the specific metric used. The description of the time point(s) of assessment must be specific to the outcome measure and is generally the specific duration of time over which each participant is assessed (not the overall duration of the study).
Measured: Up to 96 weeks (from date of consent until the date of first documented progression)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start21 Apr 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dr Andreas Makris, Principal investigator, East and North Hertfordshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266744
- Sponsor's protocol ID
- RD2015-64
- Acronym
- RESPECT
- Status last verified
- Aug 2017
- First submitted
- 23 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All patients can agree to their data being used for future research.
Publications
Kosmin M, Padhani AR, Gogbashian A, Woolf D, Ah-See ML, Ostler P, Sutherland S, Miles D, Noble J, Koh DM, Marshall A, Dunn J, Makris A. Comparison of Whole-Body MRI, CT, and Bone Scintigraphy for Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to Bone. Radiology. 2020 Dec;297(3):622-629. doi: 10.1148/radiol.2020192683. Epub 2020 Oct 20.
PubMed 33078998
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study
- ClinicalTrials.gov ID
- NCT03266744
- Acronym / sponsor ID
- RESPECT / RD2015-64
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Whole Body MRI, Computerised Tomography, Bone scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 30 Aug 2017 (actual)
- 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.
This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment.
Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.
Detailed description
Patients are eligible for RESPECT if they have bone-only metastatic breast cancer (MBC), as established by standard CT and bone scintigraphy, and are starting a new line of systemic therapy. This can be first line SACT or any subsequent line.
All patients undergo a baseline CT scan (thorax/abdomen/pelvis) and isotope bone scan prior to commencing their new systemic therapy. All CT and bone scans are performed according to standard departmental protocols, with no deviations required. WB-MRI are performed within 2 weeks of study entry. CT scans and WB-MRI are then performed every 12 weeks until week 96, and then every 24 weeks until the patient completes the study. The reporting radiologist who interprets the CT scans is blinded to the images and results of the WB-MRI scan and vice versa.
At study commencement Participants are required to have had a CT scan of the thorax, abdomen and pelvis and a bone scan (bone scintigraphy with technetium-99m-methylene diphosphonate) no more than 4 weeks prior to trial entry to ensure that they have bony-only metastatic disease, as defined using standard imaging. Baseline WB-MRI scans are performed within 2 weeks of entry into the study.
Participants are assessed in clinic and a baseline physical examination is undertaken. Any additional tests required for the initiation of the new SACT are performed at the discretion of the treating clinician and according to local protocols.
During the study CT scans and WB-MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in the study protocol). Scans are performed within the range of 7 days prior and 7 days after the planned 12 weekly scan interval date.
If there is evidence of equivocal disease progression on WB-MRI only, a repeat WB-MRI is undertaken between 28 and 42 days after the equivocal WB-MRI to confirm or refute the presence of progressive disease. If this confirmed disease progression, then the date of progression is defined as that of the original WB-MRI (i.e. the one performed 4-6 weeks earlier). No repeat CT scans are performed alongside the confirmatory WB-MRI.
Participants are reviewed in outpatient clinic after every imaging time point so that the results of the CT and WB-MRI can be relayed to them by their oncologist and a decision can be made about their ongoing treatment. If more frequent clinic reviews are required then these are not prohibited by the trial protocol. As with the frequency of imaging, the required trial clinic visits change to every 24 weeks after the week 96 visit. During these clinic visits a clinical assessment is made and a full physical examination undertaken. Current anti-cancer drug therapy, including any changes, are documented. Any skeletal related events are also documented. Skeletal related events are defined within the RESPECT study as:
- pathological fracture
- metastatic spinal cord compression
- radiotherapy for bone pain
- surgery to site of bone metastasis Case report forms are completed by the trial administrators at every imaging time point. These are referred to as week 12, week 24, week 36 and so forth.
Patient Imaging Questionnaires are performed at the week 12 and week 36 visits, and are completed by the patients within the radiology department soon after their CT and WB-MRI scans has been performed.
End of study
The end of the study protocol is reached when any of the following occur:
- Progressive bone and/or visceral disease is demonstrated on CT scan and WB-MRI (as defined in section X).
- Unequivocal progressive bone and/or visceral disease is demonstrated on WB-MRI alone (as defined in section X).
- CT and/or WB-MRI findings requiring intervention such as palliative radiotherapy, or a change in systemic therapy.
- Equivocal evidence of progressive bone and/or visceral disease (not meeting the full criteria for disease progression in section 7.1.3) demonstrated on WB-MRI only, with confirmation of findings on repeat WB-MRI undertaken 4-6 weeks later.
- Symptomatic skeletal disease or evidence of clinical progression of disease that necessitates a change in systemic therapy.
A repeat nuclear medicine bone scan is undertaken once the participant met one of the end of study criteria above.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main study group | Other | Diagnostic Test: Computerised Tomography, Diagnostic Test: Whole Body Magnetic Resonance Imaging, Diagnostic Test: Bone scanPatients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed. At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI. |
| WB-MRI sub-study group | Other | Diagnostic Test: Whole Body Magnetic Resonance ImagingPatients will be given the opportunity to participate in a sub-study of WB-MRI reproducibility. This involves a repeat scan of the Whole Body Magnetic Resonance Imaging (WB-MRI) diffusion-weighted sequences. This will be shorter in duration than the full WB-MRI scan and will take place within one hour of completing the full WB-MRI scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histological diagnosis of breast cancer
- Single or multiple bone metastases (no extraosseous or non-bony metastatic disease permitted)
- Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
- Aged 18 and over
- Life expectancy of over 6 months
Key exclusion criteria (4 listed)
- Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
- Absolute contraindication to MRI studies, CT scans or bone scans
- Pregnancy
- Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient before registration in the trial before patient registration.
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 |
|---|---|---|
| Computerised Tomography | Diagnostic test | Main study group |
| Whole Body Magnetic Resonance Imaging | Diagnostic test | Main study group, WB-MRI sub-study group |
| Bone scan | Diagnostic test | Main study group |
Primary outcome
Disease progression on CT and/or WB-MRI
Time frame: Up to 96 weeks (from date of consent until the date of first documented progression)
Description of the metric used to characterize the specific primary outcome measure, if not included in the primary outcome measure title.
1 secondary outcome
Disease progression on CT and/or WB-MRI
Time frame: Up to 96 weeks (from date of consent until the date of first documented progression)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 33078998Kosmin M, Padhani AR, Gogbashian A, Woolf D, Ah-See ML, Ostler P, Sutherland S, Miles D, Noble J, Koh DM, Marshall A, Dunn J, Makris A. Comparison of Whole-Body MRI, CT, and Bone Scintigraphy for Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to Bone. Radiology. 2020 Dec;297(3):622-629. doi: 10.1148/radiol.2020192683. Epub 2020 Oct 20.
- Individual participant dataSharing planned: Undecided. All patients can agree to their data being used for future research.
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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.
Dr Andreas Makris principal investigator
East and North Hertfordshire NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Computerised Tomography, Whole Body Magnetic Resonance Imaging and Bone scan in people with Metastatic Breast Cancer, run by East and North Hertfordshire NHS Trust.
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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Disease progression on CT and/or WB-MRI (time frame: Up to 96 weeks (from date of consent until the date of first documented progression)). 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 NCT03266744, 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 30 Aug 2017.