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Trial · NCT01238042

Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus

NCT01238042, Phase 1, Completed, Roswell Park Cancer Institute

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus. Trials, record NCT01238042. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01238042

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Study To Determine The Maximum Range of Light Doses At Two HPPH Doses With Acceptable Normal Tissue Toxicity For PDT Treatment Of High Grade Dysplasia,CIS or Early Adenocarcinoma In Barrett's Esophagus
NCT number
NCT01238042
Status
Completed
Phases
Phase 1
Enrollment
18 participants, actual
Lead sponsor
Roswell Park Cancer Institute
Conditions
Barrett's Esophagus, CIS, HGD
Interventions
HPPH
First posted
2010-11-10
Last updated
2014-12-02

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOptimal Light Dose24 hours
Using toxicity to normal surrounding tissue as a determinant and using two HPPH doses of PDT in HGD, CIS or early adenocarcinoma in Barrett's esophagus, to determine the optimal light dose at each HPPH dose
SecondaryToxicity to normal surrounding tissue24 hoursTo determine the tocixity to normal surrounding tissue of treating at approximately 24 hours(21-26hr) post injection of HPPH
SecondaryComparing HPPH to Photofrin5 yearsTo determine the length of time of cutaneous photosensitivity of HPPH compared to historical data on Photofrin
SecondaryEffect of injection24 hoursTo determine the effect of a 24 hours interval between injection of HPPH and light treatment
SecondaryEfficacy of Treatment5 yearsA secondary objective is to determine efficacy of treatment at each set of paraments, i.e. ability to completely resolve the CIS, HGD or early cancer.
SecondaryResolve Barrett's mucosa5 yearsAn Additional secondary objective is to determine ability of PDT to resolve the Barrett's mucosa

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01238042

GET https://conductscience.org/api/trials/v1/NCT01238042/registered