이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain (Celiac SRS)

2026년 7월 29일 업데이트: University Health Network, Toronto

A Prospective Pilot Clinical Trial of Simulation-Free Celiac Plexus Pain Ablation Using Stereotactic Body Radiotherapy in Patients With Cancer-Related Celiac Pain

This is a prospective, single-arm, pilot feasibility clinical trial designed to evaluate the feasibility and safety of a simulation-free adaptive radiotherapy workflow to enable single-session celiac plexus SBRT planning and delivery. In this trial, the treatment itself is non-investigational (standard-of-care celiac plexus SBRT) but the treatment workflow (simulation-free, using adaptive radiotherapy to compress treatment planning and delivery into a single session) is novel. Investigators hypothesize the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

A standard treatment for pain caused by cancer affecting the celiac plexus (a group of nerves in the upper abdomen behind the stomach and pancreas) is a type of radiation therapy called stereotactic body radiotherapy (SBRT). In the usual process for this type of radiation treatment, the patient would first have a special radiation planning scan called a computer tomography simulation (CTsim) to create a personalized treatment plan. The planning process usually takes 5 to 10 days, which means treatment may begin up to 2 weeks after the initial CTsim scan. Recent technology has allowed for treatment to be planned without a separate CTsim scan, called a CTsim-free workflow. In this study, investigators will use pre-existing scans (such as diagnostic imaging) to create the patient's treatment plan. On the day of treatment, the care team will use a technique called Adaptive Radiotherapy (ART) to adjust the plan based on the patient body's position and anatomy that day, allowing planning and treatment to happen in a single visit.

연구 유형

중재적

등록 (추정된)

5

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다, M5G 2M9
        • 모병
        • Princess Margaret Cancer Centre
        • 수석 연구원:
          • Michael Yan

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Subjects must have histologically or cytologically confirmed cancer that is metastatic or unresectable, and considered appropriate per the treating physician to receive celiac plexus SBRT.
  • Age >18 years. Because no data are currently available on the use of celiac axis SBRT in subjects ≤18 years of age, children are excluded from this study.
  • Performance status: ECOG Performance status ≤ 3
  • Severe retroperitoneal pain syndrome (radiates from the lower back to the upper abdomen, belt- like distribution), intensity of at least 5 on 11-point Brief Pain Inventory (BPI, average pain) scale.
  • Subjects must have anatomical involvement of the celiac plexus on the diagnostic CT, PET/CT, or MRI. This includes: Any pancreatic cancer, any other cancer that on imaging demonstrates either gross involvement of the celiac blood vessels or celiac plexus on imaging OR haziness around the celiac blood vessels that typically implies tumor engulfment.
  • Prior chemotherapy or biological treatment is allowed, but any active oncological treatment should be stopped at least 1 week prior to radiation therapy and renewed at least 1 week following radiation therapy.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  • Subjects must have a diagnostic CT of the abdomen and pelvis, with or without contrast, acquired < 28 days prior to the study consent.

Exclusion Criteria:

  • In ability to tolerate lying supine and still for at least 45 minutes.
  • Performance status: ECOG Performance status of 4.
  • Previous radiotherapy to the upper abdomen overlapping with the projected site of treatment.
  • Pregnant or breastfeeding women are excluded from this study.
  • Subjects with conditions associated with increased risk of side effects from radiation such as inflammatory bowel disease and scleroderma.
  • Women of childbearing potential must have a negative pregnancy test within 14 days of study entry. If pregnancy test is not clinically indicated as determined by treating physician or protocol principal investigator, documentation of this exception is sufficient in lieu of a pregnancy test.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Sim-free ART workflow
다른: Treatment plan
Simulation-free radiation treatment planning, in which pre-existing diagnostic images are used to generate a radiation treatment pre-plan (as opposed to acquiring planning-specific image sets). This will be paired with the use of online adaptive radiotherapy (ART) to refine the pre-plan to create a final plan that matches the on-table internal target and gastrointestinal anatomy observed with on-board imaging on the day of treatment. This enables single-session celiac plexus SBRT planning and delivery.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Successful treatment plan workflow of 80% of patients
기간: 1 year

The feasibility and safety of the simulation-free adaptive radiotherapy workflow for celiac plexus SBRT for clinical use. Feasibility defined as the successful completion of the simulation-free ART workflow through treatment delivery in the first on-table treatment attempt for at least 80% of patients.

All of the following criteria must be met to be deemed feasible:

  • Meets all priority 1 OAR constraints
  • Meets a PTV_Opt_2500 and PTV_Opt_2000 priority 2 constraints
  • Patient specific QA pass as per institutional standards
  • Patient able to tolerate treatment position for CBCT and entirety of treatment process. If a break is required and the patient is repositioned, the ART process must repeat from CBCT acquisition
  • Complete delivery of all planned monitor units
1 year

2차 결과 측정

결과 측정
측정값 설명
기간
Component time
기간: 1 year
Average time required for each component of the simulation-free ART workflow, including but not limited to plan generation using diagnostic imaging, pre-treatment activities (e.g., on-table patient setup/imaging, dose prediction, segmentation of daily contours, plan optimization and evaluation), and treatment delivery.
1 year
Dosimetric comparison of radiation plans
기간: 1 year
Dosimetric comparison of radiation plans created on traditional offline CBCT images with those created using the simulation-free ART workflow (i.e., comparison of target coverage, sparing of organs-at-risk).
1 year
Frequency of online re-adaptation
기간: 1 Year
Frequency of online re-adaptation within the sim-free workflow. Readaptation defined as the need to regenerate a treatment plan after an initial plan had been generated that does not satisfy treatment parameters.
1 Year
Patient satisfaction
기간: 1 year
Overall patient satisfaction with celiac plexus SBRT using a simulation-free, adaptive radiotherapy workflow. This will be assessed using the Radiotherapy Experience Questionnaire (RTEQ) which is a validated RT experience questionnaire that reports patient experiences with the overall treatment process by answering statements on a scale of strongly agree to strongly disagree. Given that this is a novel workflow/process, the results of the questionnaire will shed light on their overall experience.
1 year
TCAE Grade 3+ Toxicity
기간: 6 weeks
Any CTCAE Grade 3+ Toxicity at 6 weeks related to the SBRT treatment.
6 weeks
Cost of workflow
기간: 1 year
The overall cost of simulation free workflow compared to select retrospective cases treated on conventional workflow. Timepoints include simulation, planning, treatment, and follow up. Components include planning, therapist, clinician.
1 year
Mean difference between diagnostic and ETHOS plans (COM)
기간: 1 year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include center of mass (COM).
1 year
Mean difference between diagnostic and ETHOS plans (DTA)
기간: 1 year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include distance to agreement (DTA).
1 year
Mean difference between diagnostic and ETHOS plans (ASSD)
기간: 1 year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include average symmetric surface distance (ASSD).
1 year
Mean difference between diagnostic and ETHOS plans (DSC)
기간: 1 Year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include dice for volume overlap (DSC).
1 Year
Mean difference between diagnostic and ETHOS plans (DVF)
기간: 1 Year
Mean difference in location between diagnostic, planning, and hypersight scans at each time point for select organs at risk. These include liver, stomach, duodenum, pancreas, kidneys, small bowel, aorta, and large bowel. Rigid registration to spinal column as baseline (or aorta). Metrics will include deformation vector field (DVF).
1 Year
Change in the Brief Pain Inventory pain scale
기간: 6 Weeks
Change in Brief Pain Inventory pain scale, where on a scale 0 is "No Pain" and 10 is "Pain as bad as you can imagine", recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT.
6 Weeks
Change in Amount of Pain Medication
기간: 6 weeks
Change in the amount of pain medications (Morphine equivalents) recorded in the pain diary at baseline/screening, day of SBRT prior to treatment, and 6 weeks after sim-free celiac plexus SBRT. Patients will record number of medication units taken (unit of medication is a tablet or capsule, a millilitre (mL) of liquid, a suppository, or a patch).
6 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University Health Network, Toronto

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 4일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2027년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 26일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 25-5377

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다