En undersökningsskanning (hpMRI) för övervakning av behandlingssvar hos patienter med sköldkörtelcancer och andra maligniteter i huvud och nacke som genomgår strålbehandling och/eller systemisk terapi
Pilotstudie av metabolisk vägledning för terapi hos patienter med sköldkörtelcancer och andra maligniteter i huvud och nacke
This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To obtain pilot metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods in patients with thyroid tumors or other malignancies of the head and neck receiving radiation therapy (XRT) and/or systemic therapy (e.g., target therapy, checkpoint inhibitors).
SECONDARY OBJECTIVE:
I. To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy.
OUTLINE: Participants are assigned to 1 of 2 arms.
ARM I: Healthy volunteers undergo MRI over 30 minutes.
ARM II: Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate intravenously (IV) over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician.
After completion of study intervention, thyroid cancer and other malignancies of the head and neck patients are followed up at 1 day.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Stephen Y Lai
- Telefonnummer: 713-792-6528
- E-post: sylai@mdanderson.org
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Rekrytering
- M D Anderson Cancer Center
-
Kontakt:
- Stephen Y. Lai
- Telefonnummer: 713-792-6528
-
Huvudutredare:
- Stephen Y. Lai
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Be willing and able to provide informed consent
- Be informed of the investigational nature of this study
- Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment
Exclusion Criteria:
- Have a history of severe claustrophobia
- Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI)
- Have a history of cardiac arrhythmia
- Have an allergy to Gadavist intravenous contrast
- Estimated glomerular filtration rate (eGFR) < 30
- If female, be pregnant or breast feeding at time of consent
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm I ( Health Volunteer MRI)
Healthy volunteers undergo MRI over 30 minutes. |
Undergo MRI
Andra namn:
Undergo hpMRI
Andra namn:
|
|
Experimentell: Arm II (Thyroid Cancer Patient and other malignancies of the head and neck hpMRI)
Patients with thyroid cancer and other malignancies of the head and neck undergo hpMRI over 30 minutes at baseline, and at 1 week after the initiation of treatment. During the scan, patients also receive hyperpolarized 13-C-pyruvate IV over 30 seconds and may receive a standard MRI contrast agent at the discretion of the treating physician. |
Undergo MRI
Andra namn:
Undergo hpMRI
Andra namn:
Given IV
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods
Tidsram: 1 year
|
To measure metabolic imaging data or information derived from hyperpolarized pyruvate MRI (hpMRI) that can be used to identify an early indication of response to therapy in patients with thyroid cancer. Specifically, we measure the kPL-the apparent rate constant for conversion of HP pyruvate into lactate-after one week of treatment compared to baseline measurements acquired prior to start of therapy. The kPL will be calculated from dynamic images of HP pyruvate and its metabolites. The kPL values will be calculated for each tumor and its adjacent tissue by a radiologist and physicist in conjunction using region of interest analysis to identify the margins of the tumor and surrounding normal tissue. |
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Early metabolic changes
Tidsram: 1 year
|
To assess early metabolic changes in response to nonsurgical therapy, including standard-of-care fractionated XRT and/or systemic therapy. The imaging biomarker for tumor metabolism, kPL, will be calculated from dynamic images of HP pyruvate and its metabolites. |
1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Stephen Y Lai, M.D. Anderson Cancer Center
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020-0482
- 2020-0482 (Annan identifierare: M D Anderson Cancer Center)
- NCI-2020-05843 (Registeridentifierare: NCI-CTRP Clinical Trials Registry)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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