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Fluorocholine PET/MR in Breast Cancer

8. maj 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

195

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 11217
        • Rekruttering
        • Taipei Veterans General Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Jane Wang, M.D.
        • Underforsker:
          • Ling-Ming Tseng, M.D
        • Underforsker:
          • Ko-Han Lin, M.D.
        • Underforsker:
          • Yi-Fang Tsai, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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).
Diagnostisk test: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taipei Veterans General Hospital, Taiwan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. juni 2022

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

8. maj 2026

Først indsendt, der opfyldte QC-kriterier

8. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2020-03-005A

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