Breast Cancer (Locally Advanced or Metastatic)NCT07523516
Diagnostic Performance of 18F-FDG PET/CT in Detecting Distant Metastases in Breast Cancer
An observational study of Breast Cancer (Locally Advanced or Metastatic), run by Assiut University.
Trial summary
compare the accuracy and sensitivity of 18F FDG-PET/CT and CE-CT in detecting distant metastases in breast cancer Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer (Locally Advanced or Metastatic)
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Apr 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with metastatic breast cancer
- Inclusion criteria:
- Patients with pathologically proven breast cancer
- Metastatic breast cancer proved by pathology or radiological modalities.
- Interval between 18F-FDG PET/CT and CE-CT from one to three weeks.
- Exclusion criteria:
- Patients with known concomitant malignancy
- Patients receive systemic treatment chemotherapy or radiotherapy between 18F-FDG PET/CT and CE-CT.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diagnostic Performance of F18-FDG PET/CT in Detecting Distant Metastases in Breast Cancer
compare the accuracy and sensitivity of 18F FDG-PET/CT and CE-CT in detecting distant metastases in breast cancer
Read the detailed description
Breast cancer is the most common cancer type and the most common cause of death in women worldwide.
Breast cancer patients with large tumours (T3) have a 8.3%-15.1% risk for distant metastasis. Metastatic breast cancer (MBC) is considered an incurable disease with a 5-year overall survival of only 25%.
Effective management of breast cancer requires accurate diagnosis and determination of the extent of the disease to select the most effective treatment approach. Breast cancer is very heterogenous and is characterized by different pathological features, with distinct responses to treatment and differences in long-term patient survival.
Various imaging modalities have been suggested for diagnosing MBC; however, contrast-enhanced computed tomography (CE-CT) and bone scintigraphy are often used in clinical practice. However, CE-CT has low sensitivity for bone metastases and low specificity for liver metastases.
CE-CT and the corresponding response evaluation criteria in solid tumours (RECIST) are methods that assess changes in structural lesions, making it challenging to differentiate between active tumour tissue and scar lesions [18F]-fluorodeoxyglucose-positron emission tomography/computed tomography ([18F] FDG-PET/CT) is a glucose analog transported via glucose transporters into the cells and phosphorylated by hexokinase .FDG follows the same pathway as glucose during the first enzymatic reactions in the cells, but because FDG lacks a hydroxyl group at the C-2 position, it is not metabolized further and is physically trapped in tumor cells at a rate proportional to glucose utilization.
Malignant cells show higher glucose metabolism and increased glycolytic activity compared to non-malignant cells (10). This high glycolytic activity eases the detection of malignant cells using [18F] FDG-PET/CT) imaging. so, [18F] FDG-PET/CT can detect changes in metabolic activity before morphologic changes can be seen.
However, the exact clinical stage at which PET/CT can be performed with well-balanced cost-effectiveness is uncertain till now .
- Keywords
- breast cancer, metastatic, CE-CT
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
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 |
|---|---|---|
| Breast cancer Patients | 18 FDG PET CT scan for metastatic breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.
Measured: 12 months
Secondary outcomes (1)
Early staging and clinical management of breast cancer in attempt to improve survival and quality of life
Early staging and clinical management of breast cancer in attempt to improve survival and quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer (Locally Advanced or Metastatic)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Sharef Eid Ahmed, Assiut University
- Investigators
- Hebatallah Ahmed Abdelraof, Professor, Principal investigator, nuclear medicine unit Assiut university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523516
- Sponsor's protocol ID
- AssuitUfacultyProtocol19962026
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Niikura N, Costelloe CM, Madewell JE, Hayashi N, Yu TK, Liu J, Palla SL, Tokuda Y, Theriault RL, Hortobagyi GN, Ueno NT. FDG-PET/CT compared with conventional imaging in the detection of distant metastases of primary breast cancer. Oncologist. 2011;16(8):1111-9. doi: 10.1634/theoncologist.2011-0089. Epub 2011 Jul 17.
PubMed 21765193Paydary K, Seraj SM, Zadeh MZ, Emamzadehfard S, Shamchi SP, Gholami S, Werner TJ, Alavi A. The Evolving Role of FDG-PET/CT in the Diagnosis, Staging, and Treatment of Breast Cancer. Mol Imaging Biol. 2019 Feb;21(1):1-10. doi: 10.1007/s11307-018-1181-3.
PubMed 29516387Vercher-Conejero JL, Pelegri-Martinez L, Lopez-Aznar D, Cozar-Santiago Mdel P. Positron Emission Tomography in Breast Cancer. Diagnostics (Basel). 2015 Mar 16;5(1):61-83. doi: 10.3390/diagnostics5010061.
PubMed 26854143Zangheri B, Messa C, Picchio M, Gianolli L, Landoni C, Fazio F. PET/CT and breast cancer. Eur J Nucl Med Mol Imaging. 2004 Jun;31 Suppl 1:S135-42. doi: 10.1007/s00259-004-1536-7. Epub 2004 May 5.
PubMed 15133636Vogsen M, Harbo F, Jakobsen NM, Nissen HJ, Dahlsgaard-Wallenius SE, Gerke O, Jensen JD, Asmussen JT, Jylling AMB, Braad PE, Vach W, Ewertz M, Hildebrandt MG. Response Monitoring in Metastatic Breast Cancer: A Prospective Study Comparing 18F-FDG PET/CT with Conventional CT. J Nucl Med. 2023 Mar;64(3):355-361. doi: 10.2967/jnumed.121.263358. Epub 2022 Oct 7.
PubMed 36207136Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1.
PubMed 33812473Hadebe B, Harry L, Ebrahim T, Pillay V, Vorster M. The Role of PET/CT in Breast Cancer. Diagnostics (Basel). 2023 Feb 6;13(4):597. doi: 10.3390/diagnostics13040597.
PubMed 36832085Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, Andre F, Barrios CH, Bergh J, Bhattacharyya GS, Biganzoli L, Boyle F, Cardoso MJ, Carey LA, Cortes J, El Saghir NS, Elzayat M, Eniu A, Fallowfield L, Francis PA, Gelmon K, Gligorov J, Haidinger R, Harbeck N, Hu X, Kaufman B, Kaur R, Kiely BE, Kim SB, Lin NU, Mertz SA, Neciosup S, Offersen BV, Ohno S, Pagani O, Prat A, Penault-Llorca F, Rugo HS, Sledge GW, Thomssen C, Vorobiof DA, Wiseman T, Xu B, Norton L, Costa A, Winer EP. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020 Dec;31(12):1623-1649. doi: 10.1016/j.annonc.2020.09.010. Epub 2020 Sep 23. No abstract available.
PubMed 32979513Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
PubMed 21351269
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of F18-FDG PET/CT in Detecting Distant Metastases in Breast Cancer
- ClinicalTrials.gov ID
- NCT07523516
- Acronym / sponsor ID
- AssuitUfacultyProtocol19962026
- Keywords
- breast cancer, metastatic, CE-CT
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 13 Apr 2026 (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.
compare the accuracy and sensitivity of 18F FDG-PET/CT and CE-CT in detecting distant metastases in breast cancer
Detailed description
Breast cancer is the most common cancer type and the most common cause of death in women worldwide.
Breast cancer patients with large tumours (T3) have a 8.3%-15.1% risk for distant metastasis. Metastatic breast cancer (MBC) is considered an incurable disease with a 5-year overall survival of only 25%.
Effective management of breast cancer requires accurate diagnosis and determination of the extent of the disease to select the most effective treatment approach. Breast cancer is very heterogenous and is characterized by different pathological features, with distinct responses to treatment and differences in long-term patient survival.
Various imaging modalities have been suggested for diagnosing MBC; however, contrast-enhanced computed tomography (CE-CT) and bone scintigraphy are often used in clinical practice. However, CE-CT has low sensitivity for bone metastases and low specificity for liver metastases.
CE-CT and the corresponding response evaluation criteria in solid tumours (RECIST) are methods that assess changes in structural lesions, making it challenging to differentiate between active tumour tissue and scar lesions [18F]-fluorodeoxyglucose-positron emission tomography/computed tomography ([18F] FDG-PET/CT) is a glucose analog transported via glucose transporters into the cells and phosphorylated by hexokinase .FDG follows the same pathway as glucose during the first enzymatic reactions in the cells, but because FDG lacks a hydroxyl group at the C-2 position, it is not metabolized further and is physically trapped in tumor cells at a rate proportional to glucose utilization.
Malignant cells show higher glucose metabolism and increased glycolytic activity compared to non-malignant cells (10). This high glycolytic activity eases the detection of malignant cells using [18F] FDG-PET/CT) imaging. so, [18F] FDG-PET/CT can detect changes in metabolic activity before morphologic changes can be seen.
However, the exact clinical stage at which PET/CT can be performed with well-balanced cost-effectiveness is uncertain till now .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer Patients | – | –18 FDG PET CT scan for metastatic breast cancer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with metastatic breast cancer
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
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.
Time frame: 12 months
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.
1 secondary outcome
Early staging and clinical management of breast cancer in attempt to improve survival and quality of life
Time frame: 12 months
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 13 Apr 2026.
- Background: PubMed 21765193Niikura N, Costelloe CM, Madewell JE, Hayashi N, Yu TK, Liu J, Palla SL, Tokuda Y, Theriault RL, Hortobagyi GN, Ueno NT. FDG-PET/CT compared with conventional imaging in the detection of distant metastases of primary breast cancer. Oncologist. 2011;16(8):1111-9. doi: 10.1634/theoncologist.2011-0089. Epub 2011 Jul 17.
- Background: PubMed 29516387Paydary K, Seraj SM, Zadeh MZ, Emamzadehfard S, Shamchi SP, Gholami S, Werner TJ, Alavi A. The Evolving Role of FDG-PET/CT in the Diagnosis, Staging, and Treatment of Breast Cancer. Mol Imaging Biol. 2019 Feb;21(1):1-10. doi: 10.1007/s11307-018-1181-3.
- Background: PubMed 26854143Vercher-Conejero JL, Pelegri-Martinez L, Lopez-Aznar D, Cozar-Santiago Mdel P. Positron Emission Tomography in Breast Cancer. Diagnostics (Basel). 2015 Mar 16;5(1):61-83. doi: 10.3390/diagnostics5010061.
- Background: PubMed 15133636Zangheri B, Messa C, Picchio M, Gianolli L, Landoni C, Fazio F. PET/CT and breast cancer. Eur J Nucl Med Mol Imaging. 2004 Jun;31 Suppl 1:S135-42. doi: 10.1007/s00259-004-1536-7. Epub 2004 May 5.
- Background: PubMed 36207136Vogsen M, Harbo F, Jakobsen NM, Nissen HJ, Dahlsgaard-Wallenius SE, Gerke O, Jensen JD, Asmussen JT, Jylling AMB, Braad PE, Vach W, Ewertz M, Hildebrandt MG. Response Monitoring in Metastatic Breast Cancer: A Prospective Study Comparing 18F-FDG PET/CT with Conventional CT. J Nucl Med. 2023 Mar;64(3):355-361. doi: 10.2967/jnumed.121.263358. Epub 2022 Oct 7.
- Background: PubMed 33812473Loibl S, Poortmans P, Morrow M, Denkert C, Curigliano G. Breast cancer. Lancet. 2021 May 8;397(10286):1750-1769. doi: 10.1016/S0140-6736(20)32381-3. Epub 2021 Apr 1.
- Background: PubMed 36832085Hadebe B, Harry L, Ebrahim T, Pillay V, Vorster M. The Role of PET/CT in Breast Cancer. Diagnostics (Basel). 2023 Feb 6;13(4):597. doi: 10.3390/diagnostics13040597.
- Background: PubMed 32979513Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, Andre F, Barrios CH, Bergh J, Bhattacharyya GS, Biganzoli L, Boyle F, Cardoso MJ, Carey LA, Cortes J, El Saghir NS, Elzayat M, Eniu A, Fallowfield L, Francis PA, Gelmon K, Gligorov J, Haidinger R, Harbeck N, Hu X, Kaufman B, Kaur R, Kiely BE, Kim SB, Lin NU, Mertz SA, Neciosup S, Offersen BV, Ohno S, Pagani O, Prat A, Penault-Llorca F, Rugo HS, Sledge GW, Thomssen C, Vorobiof DA, Wiseman T, Xu B, Norton L, Costa A, Winer EP. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol. 2020 Dec;31(12):1623-1649. doi: 10.1016/j.annonc.2020.09.010. Epub 2020 Sep 23. No abstract available.
- Background: PubMed 21351269Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
- Related InfoLink provided by the sponsor.
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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.
Hebatallah Ahmed Abdelraof, Professor principal investigator
nuclear medicine unit Assiut university
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer (Locally Advanced or Metastatic), run by Assiut University.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. 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?
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?
Contact Seham Sharef Eid, Master's degree (00201097515105, Seham.14224009@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between 18F-FDG PET/CT and CT in detecting distant metastases. (time frame: 12 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 NCT07523516, which also lists 9 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 13 Apr 2026.