Softwarově podporované zobrazování (Morfeus) pro potvrzení pokrytí nádorem ablací u pacientů s nádory jater, studie COVER-ALL
Klinický dopad volumetrické zobrazovací metody pro potvrzení pokrytí nádorem ablací na pacienty s maligními jaterními lézemi (COVER-ALL)
This phase II trial studies how well software-aided imaging works in confirming tumor coverage with ablation (the removal or destruction of a body part or tissue or its function) on patients with liver tumors. The current standard for targeting tumor cells and evaluating the outcome of a liver ablation procedure is a visual inspection of the pre- and post-procedure computed tomography (CT) scans. Software-aided imaging systems, such as Morfeus, may help to improve the accuracy and effectiveness of liver ablation.
Přehled studie
Postavení
Podmínky
Detailní popis
PRIMARY OBJECTIVE:
I. To evaluate if the intra-procedure feedback of a biomechanical deformable registration volumetric image method during percutaneous ablation will increase the minimal ablation margins on a three-dimensional computed tomography-generated analysis.
SECONDARY OBJECTIVES:
I. To assess whether applying the proposed method during percutaneous ablation improves local tumor progression-free survival (LTPFS) rates.
II. Evaluate impact of software use on procedure workflow.
III. Impact of software use on complication rates, quality of life, liver function.
IV. Evaluate oncological outcomes (intra-hepatic and overall progression-free survivals, and overall survival).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care ablation.
ARM II: Patients undergo standard of care ablation with software-aided imaging (Morfeus).
After completion of study, patients are followed up at 1, 3, and 6 months, and then at 1 and 2 years.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Texas
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Houston, Texas, Spojené státy, 77030
- M D Anderson Cancer Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patients presenting with ≤ 3 liver tumors (biopsy-proven or documented by imaging) measuring 1 to 5 cm planned to undergo percutaneous thermal ablation with either microwave or radiofrequency ablation. Patients with more than 3 tumors might also be eligible in case other tumors can be treated with another curative-intended loco-regional therapy (i.e. surgical resection, radiation therapy).
- Ability to completely cover the target tumor with at least a 5 mm ablation margin.
- Written informed consent to voluntarily participate in the study and follow-up CT scan schedule
- Age > 18 years-old
- Performance status 0-2 (Eastern Cooperative Oncology Group Classification [ECOG])
- Target tumor should be visualized on contrast-enhanced CT
- Adequate glomerular filtration rate
Exclusion Criteria
- Active bacterial infection or fungal infection on the day of the ablation that, in the opinion of the investigator, would interfere with safe delivery of the study procedure or with the interpretation of study results.
- Platelet < 50,000/mm3.
- INR > 1.5
- Patients with uncorrectable coagulopathy.
- Currently breastfeeding or pregnant (latter confirmed by serum pregnancy test).
- Physical or psychological condition which would impair study participation.
- ASA (American Society of Anesthesiologists) score of > 4.
- Any other loco-regional therapies at the target lesion(s) within 30 days of the ablation procedure.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Arm I (standard of care ablation)
Patients undergo standard of care ablation. |
Ancillary studies
Ostatní jména:
Ancillary studies Undergo standard of care ablation
Ostatní jména:
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Experimentální: Arm II (standard of care ablation, software-aided imaging)
Patients undergo standard of care ablation with software-aided imaging (Morfeus). |
Ancillary studies
Ostatní jména:
Ancillary studies Undergo standard of care ablation
Ostatní jména:
Undergo software-aided imaging (Morfeus)
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Minimal Ablative Margin Assessment on Post-ablation Intraprocedural CT.
Časové okno: Visit 2 (baseline/ablation day)
|
For control group, MAM was assessed by rigid co-registration with side-by-side juxtaposition to verify applicator placement and by visual landmark-based CT measurements on CT workstation (Siemens Healthineers; Forchheim, Germany). For experimental group, CT images were processed with a software-based method on a radiation treatment planning system (Raystation, RaySearch Laboratories; Stockholm, Sweden) with biomechanical deformable imaging registration coupled with AI-based autosegmentation. For experimental group, interventional radiologist (IR) was informed of ablation applicator position relative to tumor on non-contrast CT before thermal ablation energy delivery and of MAM results (including spatial location of suboptimal margins) generated by software-based assessment, with this information not disclosed to IR in control group. Software-based assessment was used to compare MAMs results between both study groups with a two-sample t-test. |
Visit 2 (baseline/ablation day)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cumulative Incidence of 2-year Local Tumor Progression
Časové okno: Time to local tumor progression (LTP) was measured from ablation to earliest LTP or death (competing event). Follow-up imaging continued up to 24 months.
|
A competing risk analysis was conducted to estimate the 2-year cumulative incidence of local tumor progression. Progression followed ablation reporting standards and RECIST v1.1 (mRECIST for HCC). |
Time to local tumor progression (LTP) was measured from ablation to earliest LTP or death (competing event). Follow-up imaging continued up to 24 months.
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Overall Survival
Časové okno: Overall survival was measured from the date of ablation to the date of death from any cause. Patients still alive were censored at the date of last clinic visit, with follow-up up to 24 months after ablation.
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The Kaplan-Meier method was used to estimate overall survival |
Overall survival was measured from the date of ablation to the date of death from any cause. Patients still alive were censored at the date of last clinic visit, with follow-up up to 24 months after ablation.
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Intrahepatic Progression-free Survival (for the Randomized Group)
Časové okno: Up to 2 years
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Competing risk analysis was conducted to estimate the 2-year intrahepatic (progression outside of ablation zone), considering the progression of the ablated tumor and treating death as a competing event. |
Up to 2 years
|
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Extrahepatic Progression-free Survival
Časové okno: Up to 2 years
|
Competing risk analysis was conducted to estimate the 2-year extrahepatic cumulative incidence of progression, considering the progression of the ablated tumor and treating death as a competing event. |
Up to 2 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: BRUNO C ODISIO, M.D. Anderson Cancer Center
Publikace a užitečné odkazy
Obecné publikace
- Lin YM, Paolucci I, Anderson BM, O'Connor CS, Rigaud B, Briones-Dimayuga M, Jones KA, Brock KK, Fellman BM, Odisio BC. Study Protocol COVER-ALL: Clinical Impact of a Volumetric Image Method for Confirming Tumour Coverage with Ablation on Patients with Malignant Liver Lesions. Cardiovasc Intervent Radiol. 2022 Dec;45(12):1860-1867. doi: 10.1007/s00270-022-03255-3. Epub 2022 Sep 4.
- Odisio BC, Albuquerque J, Lin YM, Anderson BM, O'Connor CS, Rigaud B, Briones-Dimayuga M, Jones AK, Fellman BM, Huang SY, Kuban J, Metwalli ZA, Sheth R, Habibollahi P, Patel M, Shah KY, Cox VL, Kang HC, Morris VK, Kopetz S, Javle MM, Kaseb A, Tzeng CW, Cao HT, Newhook T, Chun YS, Vauthey JN, Gupta S, Paolucci I, Brock KK. Software-based versus visual assessment of the minimal ablative margin in patients with liver tumours undergoing percutaneous thermal ablation (COVER-ALL): a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2025 May;10(5):442-451. doi: 10.1016/S2468-1253(25)00024-X. Epub 2025 Mar 13.
- Siddiqi NS, Albuquerque J, Paolucci I, Lin YM, O'Connor C, Haddad A, Jones AK, Vauthey JN, Brock KK, Odisio BC. Quantifying Functional Liver Volume Loss after CT-guided Percutaneous Thermal Ablation: A COVER-ALL Trial Post Hoc Analysis. Radiol Imaging Cancer. 2026 Mar;8(2):e250385. doi: 10.1148/rycan.250385.
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2019-0213
- 2019-0213 (Jiný identifikátor: M D Anderson Cancer Center)
- NCI-2019-05762 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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