PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Tx of High Grade Sarcomas
2 mars 2021 mis à jour par: UNC Lineberger Comprehensive Cancer Center
Utility of PET/MR in Assessing Response to Neoadjuvant Radiation Therapy in the Treatment of High Grade Sarcomas
Purpose: To assess the utility of PET/MR in assessing response to neoadjuvant radiation therapy in the treatment of high grade sarcomas.
Participants: Adult patients with potentially curable high grade sarcomas that are being treated at UNC with neoadjuvant radiation therapy followed by potentially curative surgical resection.
Procedures (methods): Patients who are being treated for potentially curable high grade sarcomas with neoadjuvant radiation therapy followed by surgical resection undergo pre-treatment, mid-treatment, and post-treatment PET/MR and the response to treatment is assessed by evaluating change in size and FDG avidity. Patients then undergo curative intent resection and are followed. Their pathology is reviewed for treatment affect as is assessed by percent necrosis, size, and resection margins. Patients are followed and assessed for recurrence.
Aperçu de l'étude
Description détaillée
Investigators propose that a PET/MR study at the midpoint of radiation treatment will accurately predict which patients will respond to neoadjuvant radiation therapy.
The study will enroll patients with high-grade sarcomas as identified by preoperative biopsy that will be treated with neoadjuvant radiation into the study.
The standard of care for these patients is to receive MRI scans at pre-treatment and post-treatment time points.
Patients in this study will receive their standard pre- and post-treatment imaging in the form of PET/MR, with PET conducted simultaneously with MRI, and within the context of the study they will also receive one additional PET/MR at the end of the second week of therapy.
These patients will then receive curative intent surgery and be followed in the usual fashion and assessed for local and/or distant recurrent disease.
The pathology will be assessed for completeness of resection and percent of necrosis.
On the basis of pathology, patients will be classified as responsive or non-responsive to therapy.
Quantitative measures from PET and MRI will be computed: the change in PET tumor-mean standardized uptake value (SUV) and tumor size as assessed by MRI, from pre- to post-treatment, and from pre- to mid-treatment.
The image-based quantitative measures will be correlated with the pathology outcomes to evaluate predictability of the image measures for treatment response.
Patients will be followed with the intent of further correlating image measures with clinical outcomes.
Type d'étude
Interventionnel
Inscription (Réel)
3
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- UNC-Chapel Hill
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 99 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Age ≥ 18 years of age (no upper age limit)
- Signed, IRB-approved written informed consent
- Must have a biopsy-proven high-grade retroperitoneal or soft tissue extremity sarcoma confirmed by independent evaluation of a UNC sarcoma specialized pathologist.
- Must have surgically curable disease as evaluated by initial imaging by our UNC surgeons.
- Must be in acceptable health to undergo radiation therapy and curative intent surgery as assessed by UNC surgeons and radiation oncologist.
- Must be able to understand and comply with study procedures for the entire length of the study.
- Must receive their neoadjuvant radiation therapy and curative intent surgery at UNC Hospitals - Chapel Hill location.
- Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to each PET/MRI
Exclusion Criteria:
- Inability to tolerate MRI (e.g., inability to lie flat for >1 hour)
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Poorly controlled diabetes mellitus
- Creatinine > 1.8 mg/dL OR GFR < 30mL/min
- Body Mass Index (BMI) > 35
- Active vaginal bleeding requiring packing and emergent radiation therapy
- Pregnancy or lactating female
- History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years
- Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
- Evidence of distant disease on physical exam or initial imaging
- Medical conditions precluding radiation therapy or curative intent surgery
- Previous radiation exposure precluding radiation therapy
- Had serious reaction to contrast agent
- Incarcerated or otherwise institutionalized at time of enrollment
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Single Arm: PET/MR
Each patient will undergo three combined PET/MR scans.
The pre-treatment PET, mid-treatment PET and MR, and post-treatment PET are for research purposes and not part of the patient's standard of care (pre-treatment MR and post-treatment MR).
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Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist.
At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR.
The patient will the complete their radiation therapy.
Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PET Activity Estimates at Midpoint of Treatment as Compared to Baseline
Délai: At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
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Primary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the midpoint of treatment as compared to baseline.
The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan at the end of the second week of therapy.
Treatment response will be determined on final pathological evaluation of the resected specimens in patients who undergo curative intent surgery after neoadjuvant radiation in high grade sarcomas.
This will be measured by a single sarcoma specialized pathologist and will be categorized as to the percentage of necrosis, with >90% necrosis considered to be complete response.
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At the end of the second week of radiation therapy, a mid-treatment PET/MR is obtained.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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PET Activity Estimates at Endpoint of Treatment as Compared to Baseline
Délai: A post-treatment PET/MR is obtained at 4 weeks post radiation.
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A secondary endpoint is the determination of differences among response groups in PET activity estimates from PET/MR imaging at the endpoint of treatment as compared to baseline.
The measure is computed as the change in mean SUV from the baseline PET-MR scan to the scan taken four weeks after completion of therapy.
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A post-treatment PET/MR is obtained at 4 weeks post radiation.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: David Lalush, PhD, UNC Biomedical Engineering
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 avril 2018
Achèvement primaire (Réel)
30 décembre 2019
Achèvement de l'étude (Réel)
31 janvier 2020
Dates d'inscription aux études
Première soumission
6 mars 2017
Première soumission répondant aux critères de contrôle qualité
6 mars 2017
Première publication (Réel)
10 mars 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 mars 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
2 mars 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- LCCC 1615
Plan pour les données individuelles des participants (IPD)
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INDÉCIS
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
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