NCT01766622

18F-CP18 Imaging Studies for Cancer Treatment With Birinapant

Withdrawn Phase 2 Last updated 4 December 2019

What this trial tests

Phase 2 trial testing [18F]-CP18 in Ovarian Neoplasms. Withdrawn.

Timeline

30 November 2012

Primary endpoint
24 July 2013

24 July 2013

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	diagnostic
Start date	30 November 2012
Primary completion	24 July 2013
Estimated completion	24 July 2013

Drugs / interventions tested

• [18F]-CP18 — full drug profile →
• PET/ CT

Conditions studied

• Ovarian Neoplasms — all drugs for Ovarian Neoplasms →
• Ovarian Cancer — all drugs for Ovarian Cancer →
• Fallopian Tube Neoplasms — all drugs for Fallopian Tube Neoplasms →
• Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 99, female only, with Ovarian Neoplasms or Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
   Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
2. Molecular Imaging of Apoptosis: The Case of Caspase-3 Radiotracers.
   Beroske L, Van den Wyngaert T, Stroobants S, Van der Veken P, et al · · 2021 · cited 66× · PMID 33920463 · DOI 10.3390/ijms22083948
3. Potency and Selectivity of SMAC/DIABLO Mimetics in Solid Tumor Therapy.
   Zhao XY, Wang XY, Wei QY, Xu YM, et al · · 2020 · cited 31× · PMID 32325691 · DOI 10.3390/cells9041012
4. SPECT and PET radiopharmaceuticals for molecular imaging of apoptosis: from bench to clinic.
   Wang X, Feng H, Zhao S, Xu J, et al · · 2017 · cited 24× · PMID 28108738 · DOI 10.18632/oncotarget.14730
5. Apoptosis Imaging in Oncology by Means of Positron Emission Tomography: A Review.
   Van de Wiele C, Ustmert S, De Spiegeleer B, De Jonghe PJ, et al · · 2021 · cited 14× · PMID 33803180 · DOI 10.3390/ijms22052753
6. Augmentation of [<sup>18</sup>F]-C-SNAT4 PET imaging of apoptosis after radiotherapy using a cold mixing strategy.
   Qiu J, Chen M, Chen Z, Beinat C, et al · · 2025 · PMID 40459707 · DOI 10.1186/s13550-025-01255-1