Early Interim 18F-FDG-PET and 18F-FLT-PET for Predicting Treatment Response and Survival in Metastatic Breast Cancer

NCT04411966 | Completed

• 1 other identifier: CMRPG2C0483
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

We aim to investigate the value of 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) for early prediction of treatment response and survival in patients with metastatic breast cancer after salvage therapy.

Conditions

Metastatic Breast Cancer

Keywords

18F-fluorothymidine; 18F-fluorodeoxyglucose; Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in 18F-fluorothymidine (18F-FLT) and 18F-fluorodeoxyglucose (18F-FDG) maximal standardized uptake value (SUV) as response to therapy

  The response to therapy would be determined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) by contrast-enhanced computed tomography (CE-CT). The change of SUVmax between the responders and non responders on 18F-FLT and 18F-FDG would be compared.

  Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)

Secondary Outcomes (1)

• Compare Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) and European Organization for Research and Treatment of Cancer (EORCT) response by 18F-FLT-PET and 18F-FDG-PET for the prediction of anatomic treatment response

  Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, , each cycle is 28 days)

Other Outcomes (2)

• Progression-free survival (PFS) was defined as the time from the date of inclusion in the study to disease recurrence or progression.

  Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)

• Overall survival (OS) was defined as the time from the date of inclusion in the study to the date of death from any cause or last follow-up.

  Baseline, post 1-cycle and post 2-cycle (at least 10 days prior to or after systemic chemotherapy, each cycle is 28 days)

Study Arms (1)

18F-fluorothymidine PET

EXPERIMENTAL

Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.

Diagnostic Test: 18F-fluorothymidine

Interventions

18F-fluorothymidine DIAGNOSTIC_TEST

Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.

18F-fluorothymidine PET

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histological evidence of breast cancer of any stage
• Participants must be diagnosed with metastatic breast cancer
• Participants should be willing and able to have both PET-CT scans
• Participants should be eligible for and plan to undergo systemic chemotherapy and should be seen by a oncologist prior to beginning the study
• Participants should have the ability to understand and the willingness to sign a written informed consent document
• Participants must sign a study specific consent form prior to registration

You may not qualify if:

• Patients have been diagnosed with other malignancy
• Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded
• Pregnant women are excluded from this study
• Breast feeding women are excluded from this study

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Related Publications (1)

• Su TP, Huang JS, Chang PH, Lui KW, Hsieh JC, Ng SH, Chan SC. Prospective comparison of early interim 18F-FDG-PET with 18F-FLT-PET for predicting treatment response and survival in metastatic breast cancer. BMC Cancer. 2021 Aug 10;21(1):908. doi: 10.1186/s12885-021-08649-z.

  PMID: 34376155 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participant received 18F-FLT and 18F-FDG at baseline, after 1st cycle , and after 2nd cycle of systemic chemotherapy.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: June 2, 2020
• Study Start: January 1, 2014
• Primary Completion: August 30, 2017
• Study Completion: May 30, 2019
• Last Updated: June 2, 2020

Record last verified: 2018-05