- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07724626
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
- Navn: Ying-Chieh Lai, MD
- Telefonnummer: 2585 +88633281200
- E-mail: cappolya@gmail.com
Studiesteder
-
-
-
Taoyuan, Taiwan, 333
- Chang Gung Memorial Hospital
-
Kontakt:
- Ying-Chieh Lai, MD
- Telefonnummer: 2585 +88633281200
- E-mail: cappolya@gmail.com
-
-
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:
- 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
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.
Sponsor
Samarbejdspartnere
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DNP_GIST
- 114-2314-B-182A-118-MY3 (Anden identifikator: National Science and Technology Council (Taiwan))
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)
-
The Life Raft GroupRekrutteringGIST | Gastrointestinal stromal tumor (GIST) | GIST - Gastrointestinal Stromal TumorForenede Stater
-
Kumquat Biosciences Inc.RekrutteringGIST | Gastrointestinale tumorer | GIST - Gastrointestinal Stromal Tumor | Gastrointestinal stromal tumor | GIST Metastatisk kræftForenede Stater
-
Hospital Universitario Virgen de la ArrixacaIkke rekrutterer endnuLeversygdomme | Levertransplantation | Neoplasmer i leveren | Gastrointestinale stromale tumorer | Metastase | Levermetastaser | Levertransplantation; Komplikationer | Leverkræft | Levertransplantationslidelse | Leverkarcinom | GIST, ondartet | GIST | Metastaser | Metastatisk leverkræft | Gastrointestinal stromal tumor i... og andre forholdSpanien
-
Centre Leon BerardRekrutteringMetastatisk gastrointestinal stromal tumor | Ikke-operabel gastrointestinal stromal tumor (GIST) | Lokalt avanceret gastrointestinal stromal tumor (GIST)Frankrig
-
Kura Oncology, Inc.RekrutteringGastrointestinal stromal tumor (GIST) | Gastrointestinal stromal neoplasma | Gastrointestinal stromal tumor, ondartet | Gastrointestinal stromal cancer | Gastrointestinale stromalcelletumorerForenede Stater
-
Centre Leon BerardRekrutteringC-KIT mutation | Metastatisk gastrointestinal stromal tumor (GIST) | Avanceret gastrointestinal stromal tumor (GIST)Frankrig
-
Universität Duisburg-EssenIkke rekrutterer endnuGIST - Gastrointestinal Stromal Tumor | Gastrointestinal stromaltumor (GIST)Tyskland
-
Peking University People's HospitalTilmelding efter invitationGastrointestinal stromal tumor (GIST) | Submucosal tumor i mave-tarmkanalenKina
-
Affiliated Hospital to Academy of Military Medical...Rekruttering
-
Ningbo Newbay Technology Development Co., LtdRekrutteringGIST - Gastrointestinal Stromal Tumor | FremskredenKina, Sydkorea
Kliniske forsøg med Hyperpolarized 13C-MRI
-
University of Wisconsin, MadisonWashington University School of Medicine; National Heart, Lung, and Blood... og andre samarbejdspartnereAfsluttet
-
Chang Gung Memorial HospitalMinistry of Science and Technology, TaiwanRekrutteringImmunrelateret bivirkningTaiwan
-
Robert Bok, MD, PhDNational Cancer Institute (NCI); National Institute for Biomedical Imaging... og andre samarbejdspartnereRekrutteringAvanceret solid tumorForenede Stater
-
Xemed LLCUniversity of PennsylvaniaAfsluttet
-
Chang Gung Memorial HospitalRekrutteringHepatocellulært karcinom (HCC)Taiwan
-
University of California, San FranciscoNational Cancer Institute (NCI)RekrutteringDuktalt adenokarcinom i bugspytkirtlen | Metastatisk pancreas ductal adenokarcinom | Lokalt avanceret pancreas ductal adenocarcinomForenede Stater
-
University of Texas Southwestern Medical CenterNational Cancer Institute (NCI); Howard Hughes Medical InstituteRekrutteringNyrekræft | Nyrecellekarcinom | Urothelialt karcinom | Arvelig leiomyomatose og nyrecellekræft | Metastatisk Urothelial Carcinom | Kromofob nyrecellekarcinom | Papillært nyrecellekarcinom | HLRCC | Klarcellet karcinom | Metastatisk nyrekræft | Fumarate Hydratase mangel | Succinatdehydrogenase-deficient nyrecellekarcinomForenede Stater
-
Loma Linda UniversityAfsluttet
-
James RubensteinNational Cancer Institute (NCI)RekrutteringPrimært CNS lymfomForenede Stater
-
University Hospital Birmingham NHS Foundation TrustPancreatic Cancer UKRekrutteringPancreas eksokrin insufficiensDet Forenede Kongerige