---
title: PET Assessment of Acute Lung Transplant Rejection
nct_id: NCT02204202
overall_status: TERMINATED
sponsor: Washington University School of Medicine
study_type: OBSERVATIONAL
primary_condition: Lung Disease
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02204202.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02204202"
ct_last_update_post_date: 2020-10-08
last_seen_at: "2026-05-12T07:10:57.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# PET Assessment of Acute Lung Transplant Rejection

**Official Title:** Positron Emission Tomography Assessment of Acute Lung Transplant Rejection

**NCT ID:** [NCT02204202](https://clinicaltrials.gov/study/NCT02204202)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** PI left institution
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** Washington University School of Medicine
- **Collaborators:** National Heart, Lung, and Blood Institute (NHLBI)
- **Conditions:** Lung Disease
- **Start Date:** 2014-02
- **Completion Date:** 2017-02-04
- **CT.gov Last Update:** 2020-10-08

## Brief Summary

The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.

## Detailed Description

Positron emission tomography with fluorodeoxyglucose (FDG-PET) is a potential way we can measure lung inflammation. FDG-PET imaging is a clinically accepted and FDA-approved method that is commonly used in the diagnosis and management of cancer. PET is a machine that detects radiation and generates pictures using a donut shaped scanner similar in appearance to an x-ray "CAT" computerized axial tomography or computed tomography (CT) scan. FDG stands for \[18F\] (flourine 18) fluorodeoxyglucose, a radiolabeled sugar that is used to identify areas of inflammation with the PET scanner. A CT scan takes a picture of what the lungs and airways look like.

T cells are the primary cause of acute rejection of lung transplants. Because T cells must divide in order to be activated and cause rejection, imaging them while they are dividing is another way that we can determine whether acute rejection is occurring. A new PET tracer called \[18F\]ISO-1 (18F-labeled σ2-receptor ligand for PET, N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-18F-fluoroethoxy)-5-methylbenzamide (18F-3c), binds to dividing cells. Therefore, \[18F\]ISO-1 may help us measure acute rejection more accurately. \[18F\]ISO-1 is an investigational drug.

## Eligibility

- **Minimum age:** 19 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Double-lung transplant recipient
* Scheduled for bronchoscopy with transbronchial biopsy
* Capable of lying still and supine with arms raised above the head within the PET/CT scanner for \~1.25 hours
* Capable of following instructions for breathing protocol during CT portion of PET/CT
* Able and willing to give informed consent
* BMI \< 35
* Already scheduled to undergo bronchoscopy with bronchoalveolar lavage (BAL) for clinical reasons
* Willing to donate a portion of BAL and biopsy specimen for laboratory testing

Exclusion Criteria:

* Glucose level \> 150 mg/dl at time of \[18F\]FDG PET scan (however, up to 160 mg/dl, with repeat testing showing level is stable or decreasing, is acceptable)
* Pregnancy (confirmed by qualitative urine human chorionic gonadotropin (hCG) pregnancy test)
* Lactation
* Presence of implanted electronic medical device
* Enrollment in another research study of an investigational drug
* Inability to lie flat with arms raised above the head for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT
```

## Arms

- **Grade A0** — Double-lung transplant recipients with no evidence of rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans
- **Grades A2-3** — Double-lung transplant recipients with mild to moderate rejection who undergo both \[18F\]FDG and \[18F\]ISO-1 PET imaging scans

## Interventions

- **[18F]FDG** (DRUG) — 10 millicuries (mCi) of \[18F\]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition
- **[18F]ISO-1** (DRUG) — 8 mCi of \[18F\]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition

## Primary Outcomes

- **Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung** _(time frame: This outcome measure is assessed from the [18F]FDG scan performed on Day 1.)_
- **Logan plot analysis determined distribution volume ratio (DVR) of [18F] ISO-1 uptake** _(time frame: This outcome measure is assessed from the [18F]ISO-1 PET scan performed on Day 2.)_

## Secondary Outcomes

- **Progesterone receptor membrane component 1 (PGRMC1) staining of biopsy tissues and bronchoalveolar lavage cells** _(time frame: Assessed after the baseline clinical bronchoscopy procedure is performed 3 days prior to FDG PET/CT scan)_

## Locations (1)

- Washington University School of Medicine / Barnes-Jewish Hospital, St Louis, Missouri, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.washington university school of medicine / barnes-jewish hospital|st louis|missouri|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02204202.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02204202*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*