NCT05730608 18F-FDG PET/CT Imaging for Breast Cancer
| NCT ID | NCT05730608 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vestre Viken Hospital Trust |
| Condition | Breast Cancer Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-02-16 |
| Primary Completion | 2032-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-02-16 with a primary completion date of 2032-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment. Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC. Objectives Primary: To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment. Secondary: * Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT. * Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome. * Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome. * Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome. * Blood and tumor samples for molecular characterisation:
Eligibility Criteria
Inclusion Criteria: * Patients with high risk primary or recurrent breast cancer * Non pregnant women \> 18 years * Not receiving active treatment of other cancer types. * Eastern Cooperative Oncology Group (ECOG) status 0-2. Exclusion Criteria: * Pregnant woman * Males * Age under 18 * Patients receiving active treatment for other cancers * Poor general conditipon (ECOG 3 or higher)
Contact & Investigator
Harald Grut, MD, PHD
PRINCIPAL INVESTIGATOR
Vestre Viken Hospital Trust
Frequently Asked Questions
Who can join the NCT05730608 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05730608 currently recruiting?
Yes, NCT05730608 is actively recruiting participants. Contact the research team at harald.grut@gmail.com for enrollment information.
Where is the NCT05730608 trial being conducted?
This trial is being conducted at Drammen, Norway.
Who is sponsoring the NCT05730608 clinical trial?
NCT05730608 is sponsored by Vestre Viken Hospital Trust. The principal investigator is Harald Grut, MD, PHD at Vestre Viken Hospital Trust. The trial plans to enroll 300 participants.
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