NCT07523516

Brief Summary

compare the accuracy and sensitivity of 18F FDG-PET/CT and CE-CT in detecting distant metastases in breast cancer

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
36mo left

Started Apr 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Apr 2029

Study Start

First participant enrolled

April 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Expected
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

April 5, 2026

Last Update Submit

April 5, 2026

Conditions

Breast Cancer (Locally Advanced or Metastatic)

Keywords

breast cancer, metastatic, CE-CT

Outcome Measures

Primary Outcomes (1)

  • Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.

    Comparison between 18F-FDG PET/CT and CT in detecting distant metastases.

    12 months

Secondary Outcomes (1)

  • Early staging and clinical management of breast cancer in attempt to improve survival and quality of life

    12 months

Study Arms (1)

Breast cancer Patients

18 FDG PET CT scan for metastatic breast cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with metastatic breast cancer

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with known concomitant malignancy
  • Patients receive systemic treatment chemotherapy or radiotherapy between 18F-FDG PET/CT and CE-CT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Niikura N,Costelloe CM,Madewell JE,Hayashi N,Yu TK,Liu J,Palla SL,Tokuda Y,Theriault RL,Hortobagyi GN,Ueno NT

    BACKGROUND

  • Paydary 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.

    PMID: 29516387BACKGROUND

  • Vercher-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.

    PMID: 26854143BACKGROUND

  • Zangheri 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.

    PMID: 15133636BACKGROUND

  • Vogsen 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.

    PMID: 36207136BACKGROUND

  • Loibl 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.

    PMID: 33812473BACKGROUND

  • Hadebe 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.

    PMID: 36832085BACKGROUND

  • Cardoso 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.

    PMID: 32979513BACKGROUND

  • Ferlay 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.

    PMID: 21351269BACKGROUND

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hebatallah Ahmed Abdelraof, Professor

    nuclear medicine unit Assiut university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seham Sharef Eid, Master's degree

CONTACT

00201097515105Seham.14224009@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04