Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Hyperpolarized MRI for GIST on Imatinib (DNP_GIST)

21. juli 2026 opdateret af: Chang Gung Memorial Hospital

Integrated Precision Imaging for GIST Patients on Imatinib Therapy: Combining Hyperpolarized 13C-MRI, Metabolomics, and Radiomics

Conventional imaging methods, such as CT and MRI, are limited in evaluating GIST response to imatinib, as they mainly reflect tumor size and fail to capture early metabolic or molecular changes. This study investigates GISTs from a metabolic perspective by integrating hyperpolarized (HP) 13C-MRI, metabolomics, and radiomics. HP 13C-MRI enables real-time monitoring of metabolic flux in vivo, while NMR-based metabolomics provides systemic insights. In this single-center, prospective observational cohort study, 30 GIST patients receiving imatinib will undergo pre-treatment CT, HP 13C-MRI, metabolomics, and biopsy. Early response will be assessed at one month, with routine evaluation at four months. Patients will be categorized as responders or non-responders, and multi-omics data will be analyzed using machine learning. The study hypothesizes that metabolic changes detected by HP 13C-MRI can predict treatment response, offering reproducible, quantifiable metrics to improve evaluation and patient care.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Detaljeret beskrivelse

Conventional imaging techniques, such as CT and MRI, have limitations in assessing GIST response to imatinib. They primarily focus on tumor size, which may not reflect early therapeutic effects, as GISTs can show necrosis or cystic changes that don't correlate with viable tumor tissue reduction. These methods also fail to capture metabolic and molecular alterations within the tumor. As a result, relying solely on size changes can lead to inaccurate or delayed treatment response evaluations, underscoring the need for more advanced imaging techniques. This project is novel because it aims to investigate GISTs undergoing imatinib treatment from a metabolic perspective by integrating hyperpolarized (HP) 13C MRI, metabolomics, and radiomics. HP 13C-MRI is a cutting-edge, non-invasive, real-time dynamic imaging technique used to monitor metabolic flux in vivo. Dynamic nuclear polarization (DNP) enhances the signal of 13C-labeled probes by up to 50,000 times. With DNP, [1-13C]pyruvate can be utilized to study various metabolic pathways, including its conversion to lactate (anaerobic glycolysis), alanine (transamination), and bicarbonate (an indirect marker for the TCA cycle). In our preliminary GIST cell models, significant changes in pyruvate metabolism were observed following imatinib treatment depending on their imatinib resistance. Additionally, NMR-based metabolomics analysis of tumor tissue and blood samples will provide a comprehensive view of systemic metabolic changes. These metabolic alterations will then be linked to MRI radiomics features for a more holistic understanding of treatment response. In this single-center, cross-sectional study, a prospective trial integrates advanced MRI techniques to address clinical challenges and improve patient care in GIST treatment. This 3-year project follows a non-randomized, two-group observational cohort design with 30 GIST patients undergoing imatinib therapy at Chang Gung Memorial Hospital at Linkou (CGMH). Pre-treatment assessments include standard-of-care CT, HP 13C-MRI, 1H-NMR metabolomics, and biopsy of the tumor tissue. HP 13C-MRI will be used to assess metabolic activity in the tumors, while 1H-NMR metabolomics will provide additional insights into systemic metabolic changes. Early response assessment one month after starting imatinib will involve HP 13C-MRI and metabolomics analysis, followed by routine response evaluation at four months using standard CT. Patients will be categorized into responders and non-responders based on treatment efficacy, and data from HP 13C-MRI, metabolomics, and radiomics will be analyzed. Machine learning techniques will integrate multi-omics data for more precise response prediction. We hypothesize that metabolic changes detected through HP 13C-MRI can predict GIST response to imatinib therapy. The extent of metabolic alterations will be correlated with tumor response, providing a new way to evaluate treatment effectiveness. By combining metabolic data with radiomic tissue characteristics, we aim to track dynamic changes in GIST metabolism with reproducible, quantifiable metrics. Ultimately, the integration of HP 13C-MRI and metabolomics will offer a deeper understanding of GIST pathophysiology from a metabolic perspective and could lead to new therapeutic strategies.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

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

Studiekontakt

Studiesteder

      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital
        • Kontakt:

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

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

The study population consists of 30 patients with gastrointestinal stromal tumors (GIST) undergoing imatinib therapy at a single center. Eligible participants are adults diagnosed with GIST who receive standard-of-care imatinib treatment and undergo imaging and metabolic assessments.

Beskrivelse

Inclusion Criteria:

  1. Patients with biopsy proved GIST.
  2. Patents will undergo imatinib.
  3. Patients have measurable disease on imaging study.
  4. Patients more than 18-year-old.

Exclusion Criteria:

  1. Pregnant or breast-feeding women.
  2. Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
  3. Intercurrent illness that will affect the compliance of the patient during the MRI study (e.g., active infection, symptomatic congestive heart failure, uncontrollable angina, arrhythmia, psychiatric disorders, dyspnea, or diarrhea).
  4. Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase >20 × upper limit of normal [ULN] or bilirubin > 10 × ULN).
  5. Severe renal impairment (eGFR <30 ml/min/1.73m2).

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
Responders
GIST patients who show response to imatinib therapy, as assessed by imaging and metabolic changes.
Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.
Non-responders
GIST patients who do not show response to imatinib therapy, as assessed by imaging and metabolic changes.
Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Metabolisk aktivitet i milten målt som pyruvat-til-lactat omdannelseshastighed
Tidsramme: Dataanalyse inden for 7 dage efter HP 13C-MRI
Pyruvat-til-laktat-omdannelsen beregnet ved kinetisk modellering-baseret konverteringsrate af pyruvat-til-lactat (kPL) og modelfri metrisk (signal-til-støj-forhold og areal-under-kurve).
Dataanalyse inden for 7 dage efter HP 13C-MRI

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Ying-Chieh Lai, MD, Chang Gung Memorial Hospital, Link

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 (Anslået)

1. januar 2027

Primær færdiggørelse (Anslået)

31. juli 2028

Studieafslutning (Anslået)

31. oktober 2028

Datoer for studieregistrering

Først indsendt

21. juli 2026

Først indsendt, der opfyldte QC-kriterier

21. juli 2026

Først opslået (Faktiske)

24. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Gastrointestinal stromal tumor (GIST)

Kliniske forsøg med Hyperpolarized 13C-MRI

Abonner