REVerse Intestinal Metaplasia in the Stomach (REVISE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pyrvinium, Placebo.
- Who it may be relevant to
- Registry conditions: Gastric Intestinal Metaplasia, Gastric Precancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Therapeutic Intervention to Reverse Gastric Precancer
Overview
This study is designed to test the use of Pyrvinium vs placebo as a treatment for gastric intestinal metaplasia with features associated with increased risk of cancer. Response will be determined by assessing the extent and quality of the gastric intestinal metaplasia before and after treatment. A secondary aim will be to generate gastric organoids from patient-derived samples to test the effects of pyrvinium in vitro in patient-derived samples, and also to identify new drugs that may help reverse gastric intestinal metaplasia.
Detailed description
The proposed study is an early Phase II Clinical Trial designed to generate additional data regarding safety and efficacy for the use of Pyrvinium, an FDA-approved drug no longer in active use. The study design includes enrollment in an observational cohort for a research-focused screening upper endoscopy to document the extent and type of gastric intestinal metaplasia in patients previously diagnosed with this condition using a standardized mapping protocol (as described below). This initial screening research endoscopy is needed as current clinical care is variable (due to lack of guidelines for mapping and surveillance). The investigators anticipate enrolling 60 participants in the observational cohort for intensive gastric mapping, and then of these 60 participants, 32 eligible participants (after determining eligibility based on presence of high-risk features of the gastric intestinal metaplasia with confirmed extensive gastric intestinal metaplasia) will be included in the randomized control trial to receive either Pyrvinium (n=16) or placebo (n=16).
Treatment is planned as followed:
2 weeks of Pyrvinium vs placebo (within 3 months of initial research endoscopy).
Following the initial endoscopy, participants will receive placebo or Pyrvinium (2 mg/kg/day) by mouth once each day for a total of 14 days. The drug (or placebo) will be verified and dispensed from the investigational drug pharmacy using an IND with attention to safety and blinding to research participants and clinical research staff. The drug and placebo will be administered as liquid suspensions. Medication diary logs will be used and participants will be asked to return bottles that contained the medication.
All participants will be advised to use sunblock and wear protective clothing due to potential for sun-sensitivity.
Interventions
- Drug Pyrvinium
Pyrvinium (2 mg/kg) per day for 14 days - Drug Placebo
Placebo for 14 days
Primary outcome measures
- Change in the number of clinical biopsies with evidence of gastric intestinal metaplasia [Time frame: Screening endoscopy (baseline) to the follow-up endoscopy (4-8 weeks)]
Secondary outcome measures (5)
- Number of clinical biopsies with evidence of gastric intestinal metaplasia [Time frame: 1 year]
- Number of clinical biopsies with complete gastric intestinal metaplasia [Time frame: 1 year]
- Number of clinical biopsies with incomplete gastric intestinal metaplasia [Time frame: 1 year]
- Number of clinical biopsies with presence of parietal cells (reversal of atrophy) [Time frame: 1 year]
- Number of clinical biopsies with presence of inflammation [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Adults (including men, women, and non-binary individuals) over age 18 with known GIM with at least one high-risk feature (extensive vs limited, incomplete or mixed-type GIM, family history of stomach cancer),
- Ability to provide informed consent,
- Evidence of prior but not active H. pylori infection
Exclusion criteria
- Active gastric cancer diagnosis,
- High-risk of bleeding complications due to anticoagulants or underlying medical condition,
- Pregnancy (which is a contraindication to non-emergent endoscopy due to anesthesia risks)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke Health — Durham
Identifiers
NCT: NCT06590454 · Pro00115397 · CA230416P2