Breast NeoplasmsNCT01942759
The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Breast Cancer
An observational study of Breast Neoplasms, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2013to Jun 2014
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Female patients with breast cancer
Who may be able to join
- Newly diagnosis of breast cancer for which surgical intervention is planned
Who cannot join
- patients received neoadjuvant chemotherapy
- before breast surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training and Research Hospital
Istanbul
About this study
Official title: The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Detection of Primary Tumor and Axillary Metastasis for Breast Cancer: SUVMax Against to ADC
The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.
Read the detailed description
We aimed that to correlate both primary lesion 18F-fluorodeoxyglucose (FDG) maximum standardized uptake value (SUVmax) and diffusion-weighted imaging (DWI) apparent diffusion coefficient (ADC) with clinicopathological prognostic factors and compare the prognostic value of these indexes in breast cancer in this study. The evaluated and compared parameters are SUVmax and ADC according to age, tumour size, lymph node metastasis, receptor status, histologic grade, modified Nottingham prognostic index.
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, Positron-Emission Tomography, Diffusion Magnetic Resonance Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Histologic grade | According to the modified criteria of Bloom and Richardson grading system: grade 1, 2 and 3 | |
| Axillary metastasis | Group A: axillary lymph node metastasis Group B: no axillary lymphatic metastasis | |
| Modified Nottingham prognostic index | NPI = pathological tumour size (cm) × 0.2 + lymph node stage (1, 2 or 3) + histological grade (1, 2 or 3) The cut-off points of the index were 3.4 and 5.4 to divide patients into the good (≤3.4), moderate (3.41-5.4) and poor (>5.4) prognostic groups | |
| Oestrogen receptor status | Negative Positive | |
| Progesterone receptor status | Negative Positive | |
| HER-2 neu status | Negative Positive |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the relationships between both SUVmax and ADC and clinicopathological prognostic factors
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Aynur Ozen, Bagcilar Training and Research Hospital
- Investigators
- AYNUR OZEN, MD, Study chair, Bagcilar Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942759
- Sponsor's protocol ID
- BC-PET-MR-01
- Status last verified
- Jun 2014
- First submitted
- 2 Sep 2013
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of FDG PET/CT and Diffusion-weighed Imaging on Detection of Primary Tumor and Axillary Metastasis for Breast Cancer: SUVMax Against to ADC
- ClinicalTrials.gov ID
- NCT01942759
- Acronym / sponsor ID
- BC-PET-MR-01
- Conditions
- Breast Neoplasms
- Keywords
- Breast Neoplasms, Positron-Emission Tomography, Diffusion Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Sep 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Sep 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.
The purpose of this study is to determine findings of positron emission tomography and diffusion weighted magnetic resonance in primary lesion and axillary metastasis of breast cancer and compare of two imaging modality in these patients.
Detailed description
We aimed that to correlate both primary lesion 18F-fluorodeoxyglucose (FDG) maximum standardized uptake value (SUVmax) and diffusion-weighted imaging (DWI) apparent diffusion coefficient (ADC) with clinicopathological prognostic factors and compare the prognostic value of these indexes in breast cancer in this study. The evaluated and compared parameters are SUVmax and ADC according to age, tumour size, lymph node metastasis, receptor status, histologic grade, modified Nottingham prognostic index.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Histologic grade | – | –According to the modified criteria of Bloom and Richardson grading system: grade 1, 2 and 3 |
| Axillary metastasis | – | –Group A: axillary lymph node metastasis Group B: no axillary lymphatic metastasis |
| Modified Nottingham prognostic index | – | –NPI = pathological tumour size (cm) × 0.2 + lymph node stage (1, 2 or 3) + histological grade (1, 2 or 3) The cut-off points of the index were 3.4 and 5.4 to divide patients into the good (≤3.4), moderate (3.41-5.4) and poor (>5.4) prognostic groups |
| Oestrogen receptor status | – | –Negative Positive |
| Progesterone receptor status | – | –Negative Positive |
| HER-2 neu status | – | –Negative Positive |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients with breast cancer
Key inclusion criteria (1 listed)
- Newly diagnosis of breast cancer for which surgical intervention is planned
Key exclusion criteria (2 listed)
- patients received neoadjuvant chemotherapy
- before breast surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the relationships between both SUVmax and ADC and clinicopathological prognostic factors
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
Related trials for Breast Neoplasms
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
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.
AYNUR OZEN, MD study chair
Bagcilar Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 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 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
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?
To evaluate the relationships between both SUVmax and ADC and clinicopathological prognostic factors (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2014.