Evidence map›Paper›PMID 20800376›Full record

Trial reportInternational journal of radiation oncology, biology, physics2011

Renal shielding and dosimetry for patients with severe systemic sclerosis receiving immunoablation with total body irradiation in the scleroderma: cyclophosphamide or transplantation trial.

Oana I Craciunescu, Beverly A Steffey, Chris R Kelsey, Nicole A Larrier, Cathy J Paarz-Largay, Robert G Prosnitz, Nelson Chao, John Chute, Cristina Gasparetto, Mitchell Horwitz and 3 more

Registry-linked trialOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00114530 (A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00114530 phase2 / phase3completednot on this map

A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2005 to 2016Enrolled75ConditionsScleroderma, Systemic, Sclerosis, Autoimmune DiseaseArmsmHSCT, cyclophosphamide
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
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  12. Acute kidney injury in patients with systemic sclerosis participating in hematopoietic cell transplantation trials in the United States.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2011
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 3 institutions in 1 country.

Oana I CraciunescuDepartment of Radiation Oncology, Duke University Medical Center, Durham, NC 27710, USA. oana.craciunescu@duke.edu
Beverly A Steffey
Chris R Kelsey
Nicole A Larrier
Cathy J Paarz-Largay
Robert G Prosnitz
Nelson Chao
John Chute
Cristina Gasparetto
Mitchell Horwitz
Gwynn Long
David Rizzieri
Keith M Sullivan
Duke Medical Center · USDuke University · USUniversity of Pennsylvania · US

Funding

STEM CELL TRANSPLANTATION FOR TX OF AUTOIMMUNE DISEASES-N01AI5419N01AI005419 · NIAID · DUKE UNIVERSITY · PI SULLIVAN, KEITH M · 2000 to 2006
$6.2M
NIAID NIH HHS AI-005419NIAID NIH HHS N01 AI005419
6 · The paper itself

Abstract

purposeTo describe renal shielding techniques and dosimetry in delivering total body irradiation (TBI) to patients with severe systemic sclerosis (SSc) enrolled in a hematopoietic stem cell transplant protocol. METHODS AND MATERIALS: The Scleroderma: Cyclophosphamide or Transplantation (SCOT) protocol uses a lymphoablative preparative regimen including 800 cGy TBI delivered in two 200-cGy fractions twice a day before CD34(+) selected autologous hematopoietic stem cell transplantation. Lung and kidney doses are limited to 200 cGy to protect organs damaged by SSc. Kidney block proximity to the spinal cord was investigated, and guidelines were developed for acceptable lumbar area TBI dosing. Information about kidney size and the organ shifts from supine to standing positions were recorded using diagnostic ultrasound (US). Minimum distance between the kidney blocks (dkB) and the lumbar spine region dose was recorded, and in vivo dosimetry was performed at several locations to determine the radiation doses delivered.

resultsEleven patients were treated at our center with an anteroposterior (AP)/posteroanterior (PA) TBI technique. A 10% to 20% dose inhomogeneity in the lumbar spine region was achieved with a minimum kidney block separation of 4 to 5 cm. The average lumbar spine dose was 179.6 ± 18.1 cGy, with an average dkB of 5.0 ± 1.0 cm. Kidney block shield design was accomplished using a combination of US and noncontrast computerized tomography (CT) or CT imaging alone. The renal US revealed a wide range of kidney displacement from upright to supine positions. Overall, the average in vivo dose for the kidney prescription point was 193.4 ± 5.1 cGy.

conclusionsThe dose to the kidneys can be attenuated while maintaining a 10% to 20% dose inhomogeneity in the lumbar spine area. Kidneys were localized more accurately using both US and CT imaging. With this technique, renal function has been preserved, and the study continues to enroll patients.

Indexed as

CyclophosphamideEquipment DesignHematopoietic Stem Cell TransplantationHumansImmunosuppressive AgentsKidneyLumbar VertebraeLungOrgan SizePatient PositioningRadiation InjuriesRadiation ProtectionRadiographyRadiotherapy Planning, Computer-AssistedScleroderma, SystemicSupine PositionCyclophosphamideImmunosuppressive Agents

Identifiers

PMID20800376
PMCPMC2995833
OpenAlexW1996830034

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.