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18F-CP18 Imaging Studies for Cancer Treatment With Birinapant

NCT01766622 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-04

No results posted yet for this study

Summary

Background:

\- 18F-CP18 is a chemical designed for use in imaging studies. It is attracted to tumor cells that are being killed by cancer treatment. Researchers want to test it in imaging studies for people who are being treated with Birinapant. Birinapant is a drug used to treat advanced ovarian, fallopian tube, or peritoneal cancers. It works kills tumor cells that have not responded to earlier treatment. 18F-CP18 may help to monitor cancer treatments with this drug.

Objectives:

\- To test the effectiveness of 18F-CP18 imaging studies during cancer treatment with Birinapant.

Eligibility:

\- Individuals at least 18 years of age who are taking Birinapant for ovarian, fallopian tube, or peritoneal cancer.

Design:

* Participants will have a brief physical exam. They will also answer questions about their medical history and any current medications.
* Participants will receive a dose of 18F-CP18, followed by an imaging study. The study will involve a positron emission tomography/computed tomography (PET/CT) scan. The scan will last 40 minutes.
* There will be two more PET/CT scans 1 hour and 2 hours after taking 18F-CP18. These scans will look at how the tumor cells absorb and process 18F-CP18.
* This is a scanning study only. No treatment will be provided as part of this study.

Conditions

Interventions

DRUG

[18F]-CP18

7mCi, IV (in the vein) at baseline

PROCEDURE

PET/ CT

At baseline, Within 3 days after the initial Birinapant dose, A third \[18F\]-CP18 PET/CT will be obtained within 3 days following cycle 2, day 15 Birinapant therapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Karen A Kurdziel, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-07-24
Completion
2013-07-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01766622 on ClinicalTrials.gov