- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07724626
Hyperpolarized MRI for GIST on Imatinib (DNP_GIST)
21. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Antatt)
30
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ying-Chieh Lai, MD
- Telefonnummer: 2585 +88633281200
- E-post: cappolya@gmail.com
Studiesteder
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-
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Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
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Ta kontakt med:
- Ying-Chieh Lai, MD
- Telefonnummer: 2585 +88633281200
- E-post: cappolya@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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:
- Patients with biopsy proved GIST.
- Patents will undergo imatinib.
- Patients have measurable disease on imaging study.
- Patients more than 18-year-old.
Exclusion Criteria:
- Pregnant or breast-feeding women.
- Contraindication to MRI study (e.g., claustrophobia or non-removable devices or implants that are incompatible with MRI).
- 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).
- Severe hepatic dysfunction (alkaline phosphatase/aspartate aminotransferase/alanine aminotransferase >20 × upper limit of normal [ULN] or bilirubin > 10 × ULN).
- Severe renal impairment (eGFR <30 ml/min/1.73m2).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Responders
GIST patients who show response to imatinib therapy, as assessed by imaging and metabolic changes.
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Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.
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Non-responders
GIST patients who do not show response to imatinib therapy, as assessed by imaging and metabolic changes.
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Metabolic MRI using IV injection of hyperpolarized [1-13C]pyruvate.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Metabolsk aktivitet i milten målt som konverteringsfrekvens for pyruvat til laktat
Tidsramme: Dataanalyse innen 7 dager etter HP 13C-MRI
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Pyruvat-til-laktat-konverteringen beregnet ved kinetisk modellering-basert konverteringsrate av pyruvat-til-laktat (kPL) og modellfri metrikk (signal-til-støy-forhold og areal-under-kurve).
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Dataanalyse innen 7 dager etter HP 13C-MRI
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ying-Chieh Lai, MD, Chang Gung Memorial Hospital, Link
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. januar 2027
Primær fullføring (Antatt)
31. juli 2028
Studiet fullført (Antatt)
31. oktober 2028
Datoer for studieregistrering
Først innsendt
21. juli 2026
Først innsendt som oppfylte QC-kriteriene
21. juli 2026
Først lagt ut (Faktiske)
24. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
24. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DNP_GIST
- 114-2314-B-182A-118-MY3 (Annen identifikator: National Science and Technology Council (Taiwan))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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