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NCT Number: NCT02386709

Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Chemotherapy in Patients With Mammary Gland Cancer

Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate.

The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

FDG PET

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emilie REDERSTORFF

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient having been informed of the study
  • patient affiliated to a social health insurance
  • ≥ 18 years
  • patient presenting a breast cancer histologically confirmed
  • indication of neoadjuvant chemotherapy treatment (classification UICC: II or III)
  • patient agrees with exploitation of his clinical, biological and image data

Exclusion criteria

  • distant metastasis
  • contraindications to chemotherapy
  • contraindications to surgery
  • refusal
  • serious illness not balanced, subjacent infection
  • pregnancy or breast feeding
  • diabetes not controlled (glycemia> 8 mmol/L)
  • psychiatric disease
  • patient under supervision, trusteeship or safeguard of justice

Treatment and study plan

FDG PET

Device

FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy

Primary outcomes

  1. difference of Δ SUV (Standardised Uptak Value) between 18F-FDG PET 1 and 18F-FDG PET2 to predict pCR during neoadjuvant chemotherapy

    Time frame: early metabolic response mesure by 18F-FDG PET (difference of Δ SUV) at 3 weeks after neoadjuvant chemotherapy to predict pathologic Complete Response (pCR) by exploiting PET data realized before treatment (PET1) and after a cure of chemothrapy (PET2)

Secondary outcomes

  1. Δ SUV (Standardised Uptak Value) threshold at 3 weeks

    Time frame: Δ SUV threshold at 3 weeks allowing to show the absence of response to treatment

  2. Progression free survival

    Time frame: relation between early metabolic response (difference of Δ SUV ) assessed by 18F-FDG PET at 3 weeks and Progression-free survival

  3. modification of tumor perfusion by 18F-FDG PET

    Time frame: modifications of tumor perfusion befoire and after one cycle(3 weeks) neoadjuvant chemotherapy by exploiting PET/PDG data (PET1 and PET2)

Sponsors and collaborators

Lead sponsor

Centre Georges Francois Leclerc

Other

Registry information

Official study title

Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Treatment in Patients With Mammary Gland Cancer

Acronym: TREN

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2015
Registry last updated
Feb 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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