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Fluorocholine PET/MR in Breast Cancer

8 maggio 2026 aggiornato da: Taipei Veterans General Hospital, Taiwan

Use of Imaging Markers by Fluorocholine PET/MR to Predict Molecular Subtypes and Clinical Outcomes of Breast Cancer: a Pilot Study

Objectives:

Our study is conducted to use the pre-treatment FCH PET/MR in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (SUVmax, MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, ADC analysis), and FCH/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for prediction purposes.

Primary study purposes:

-To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose.

Secondary study purposes:

- To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for prediction purposes.

Test drug:

Name: 18F- Fluorocholine (18F-FCH) Dosage form: N-([18F]fluoromethyl)-2-hydroxy-N,N-dimethylethan-1-aminium Strength: 3-5 MBq/kg per patient (5-6 mCi/mL at time of injection (TOI)) Dosage and administration: Intravenous injection.

Selection criteria:

  1. Women aged 25-75 years old.
  2. Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).
  3. Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Study steps / procedures:

  1. The study participants will receive pre-treatment whole body PET/MR and breast PET/MR examinations.
  2. The whole body PET/MR:

1). The participant will undergo NPO for at least 6 hours before the examination.

2). After intravenous injection of 5-6 mCi/mL (at time of injection, TOI) 18F-Fluorodeoxyglucose (FDG), the participant will take a bed rest of about 60 minutes, then a 20-25 minutes of whole body PET/MR will be performed. FDG is a commercialized PET tracer and approved for clinical diagnosis.

3. PET/MR of the breast:

  1. . The participant will undergo NPO for at least 6 hours before the examination.
  2. . After intravenous injection of 5-6 mCi/mL (at TOI) 18F-Fluorocholine (FCH), the study participant will take a 45-60 minute bed rest, then undergoes a breast PET/MR with prone position. The breast PET/MR will take about 30-35 minutes. The intravenous injection of MRI contrast media will be performed during the examination (MRI-contrast media, Dotarem [Gadoteric acid, Guerbet, France] is commercialized and routinely used in MRI examination). The dosage of MRI contrast media ranges from 10-15 cc according to various body weight (0.1mmol/Kg).

4. The whole body FDG PET/MR, and the breast FCH PET/MR will be performed on different days (interval >= 2 days).

5. The study results will be interpreted by board certified diagnostic radiologists and nuclear medicine physicians, and relayed to the patient's physicians for reference of clinical management.

6. The radiation dose (effective dose equivalent, EDE) of a whole body FDG PET/MR measures about 6.6 mSv, the EDE of a FCH breast PET/MR measures about 3.85 mSv, totally about 10.45 mSv, which is relatively equivalent to that of a chest CT scan (without and with contrast, 10.8 mSv), resulting a very low estimated secondary cancer occurrence (about 5/10000 to 7/10000). Most of the radiation by FDG and FCH will be decayed, and minimal portion of them will be excreted by urine and hepatobiliary system.

Tipo di studio

Osservativo

Iscrizione (Stimato)

195

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 11217
        • Reclutamento
        • Taipei Veterans General Hospital
        • Contatto:
        • Investigatore principale:
          • Jane Wang, M.D.
        • Sub-investigatore:
          • Ling-Ming Tseng, M.D
        • Sub-investigatore:
          • Ko-Han Lin, M.D.
        • Sub-investigatore:
          • Yi-Fang Tsai, M.D.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study is conducted to use the pre-treatment FCH PET/MR in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (SUVmax, MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, ADC analysis), and FCH/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for prediction purposes.

Descrizione

Inclusion Criteria:

  • Women aged 25-75 years old.
  • Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).
  • Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.

Exclusion Criteria:

  • Women who are unable to cooperate with the examinations
  • Women who are pregnant, lactating or are planning to be pregnant
  • Women with estimated GFR (eGFR) < 60 ml/min/1.73m2 or acute renal failure within 3 months, past history of renal dialysis.
  • Past history of claustrophobia
  • Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents.
  • Women with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (<3 months).
  • Past history of breast cancer or other malignancy within 5 years.
  • Women who underwent chemotherapy within a year.
  • Women who are not suitable to join the study according to the assessment by investigators.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
Single arm
Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).
Test diagnostico: PET-MRI
  1. The study participants will receive pre-treatment whole body PET/MR and breast PET/MR examinations.
  2. The whole body PET/MR
  3. PET/MR of the breast
  4. The whole body FDG PET/MR, and the breast FCH PET/MR will be performed on different days (interval >= 2 days).
  5. The study results will be interpreted by board certified diagnostic radiologists and nuclear medicine physicians, and relayed to the patient's physicians for reference of clinical management.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose.
Lasso di tempo: From enrollment to the end of study (follow up) at least 40 weeks
To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose
From enrollment to the end of study (follow up) at least 40 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for prediction purposes.
Lasso di tempo: From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).
The results to be predicted, including: clinical outcomes (histologic grade, recurrence rate (at 1, 2, 5 years after surgery), survival (5-year overall survival and disease/recurrence-free survival).
From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Taipei Veterans General Hospital, Taiwan

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 giugno 2022

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

31 luglio 2028

Date di iscrizione allo studio

Primo inviato

8 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 maggio 2026

Primo Inserito (Effettivo)

14 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2020-03-005A

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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