NCT02751710: PET ABC

Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer

Completed NA Last updated 19 January 2024

What this trial tests

NA trial testing Whole-body FDG PET-CT alone in Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) in 369 participants. Completed in 31 March 2023.

Timeline

6 December 2016

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Ontario Clinical Oncology Group (OCOG)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	369
Start date	6 December 2016
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	6 locations across Canada

Drugs / interventions tested

• Whole-body FDG PET-CT alone

Conditions studied

• Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) — all drugs for Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) →
• Stage IIb Breast Cancer (T3N0) — all drugs for Stage IIb Breast Cancer (T3N0) →

Sponsor

Ontario Clinical Oncology Group (OCOG)

Who can join

18 and older, any sex, with Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) or Stage IIb Breast Cancer (T3N0). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is being conducted to determine the impact of whole body FDG PET-CT vs. conventional staging in the management of patients presenting with clinical Stage III breast cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients with lobular only histology will be entered into a separate single arm prospective study and will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen \& pelvis and a bone scan.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. New drugs are not enough‑drug repositioning in oncology: An update.
   Armando RG, Mengual Gómez DL, Gomez DE. · · 2020 · cited 72× · PMID 32124955 · DOI 10.3892/ijo.2020.4966
2. Impact of ¹⁸F-Labeled Fluorodeoxyglucose Positron Emission Tomography-Computed Tomography Versus Conventional Staging in Patients With Locally Advanced Breast Cancer.
   Dayes IS, Metser U, Hodgson N, Parpia S, et al · · 2023 · cited 34× · PMID 37235845 · DOI 10.1200/jco.23.00249
3. Baseline staging imaging for distant metastasis in women with stages I, II, and III breast cancer.
   Arnaout A, Varela NP, Allarakhia M, Grimard L, et al · · 2020 · cited 15× · PMID 32489262 · DOI 10.3747/co.27.6147
4. Establishing a Provincial Registry for Recurrent Prostate Cancer: Providing Access to PSMA PET/CT in Ontario, Canada.
   Young S, Metser U, Sistani G, Langer DL, et al · · 2021 · cited 13× · PMID 34408985 · DOI 10.3389/fonc.2021.722430
5. <sup>18</sup>F-FDG PET/CT of Oligometastatic Disease in Locally Advanced Breast Cancer: PETABC Trial Post Hoc Analysis.
   Metser U, Ali Mirshahvalad S, Dayes IS, Parpia S, et al · · 2025 · cited 2× · PMID 40762843 · DOI 10.1148/radiol.243788
6. Prospective study on <sup>18</sup>F-FDG PET-CT for staging locally advanced invasive lobular breast carcinoma.
   Metser U, Dayes IS, Parpia S, Eisen AF, et al · · 2026 · PMID 41772273 · DOI 10.1038/s41416-026-03362-9
7. The Outcome and Impact of Academic Cancer Clinical Trials with Participation from Canadian Sites (2015-2024).
   Xu RY, Kato D, Percival V, Schoales J, et al · · 2025 · PMID 41463258 · DOI 10.3390/cancers17244009
8. Current Approaches of Nuclear Molecular Imaging in Breast Cancer.
   Schäfer L, Altunay B, Heesch A, van Nijnatten T, et al · · 2025 · PMID 40647404 · DOI 10.3390/cancers17132105