18F ML-10 for Early Detection of Response of Brain Metastases to WBRT

NCT00791063 | Completed Phase 2 DMC

• 1 other identifier: NST-CA001CTIL
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the potential of \[18F\]-ML-10 to serve as a non-invasive imaging tool for the early detection of apoptosis in brain metastases in response to radiation therapy. Such early detection may improve clinical management of patients with brain metastases, as it may help early identification of non-responders, and subsequently potentially lead to optimization of radiation dose, early decision on focal irradiation of selected, non-responsive lesions, or early referral of the patient to surgery. The experimental design of the present study aims to evaluate the potential of non-invasive PET examination with \[18F\]-ML-10, to provide the clinician early in the course of treatment, via non-invasive molecular imaging of radiation-induced apoptosis, information on tumor responsiveness, that is currently available only several weeks to months after completion of the radiotherapy.

Conditions

Solid Tumors; Brain Metastases

Keywords

cell death; Apoptosis; PET imaging; brain metastases; whole brain radiation therapy

Outcome Measures

Primary Outcomes (1)

• Assessment of a change in the uptake of [18F]- ML-10 by the tumor as observed in comparing the PET scans before and after WBRT.

  3 months

Secondary Outcomes (4)

• Assessment of a relationship between the change in uptake of [18F]- ML-10 by the tumor, observed in the PET scans obtained during the study, and tumor shrinkage in response to treatment, as assessed by MRI or CT according to the RECIST criteria.

  3 months

• Detection of a potential change in the uptake of [18F]- ML-10 by the healthy brain tissue, as observed in comparing the PET/CT scans before and after WBRT, reflecting potential damage to intact brain tissue, as an adverse effect of the irradiation.

  3 months

• Assessment of the correlation between the PET/CT region of interest (ROI), delineated by [18F]-ML-10 imaging, and the corresponding anatomical imaging.

  3 months

• Assessment of the safety of [18F]-ML-10 when administered to cancer patients undergoing WBRT.

  one month

Study Arms (1)

18F ML-10

EXPERIMENTAL

Intervention - 18F ML-10 PET/CT imaging for early detection of response of brain metastases to WBRT

Other: 18F ML-10

Interventions

18F ML-10 OTHER

Patients will undergo 2-3 brain PET/CT sessions; A pre-treatment session and 1-2 sessions post WBRT treatment. Each PET/CT session will be done following intravenous administration of 18F-ML-10, to assess tracer uptake by the tumor.

Also known as: 18F ML-10 PET/CT imaging

18F ML-10

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cancer, diagnosed as having brain metastases, wherein at least one of the tumors has the diameter of ≥ 1.5cm, as assessed by MRI or CT performed within 14 days prior to screening/enrollment.
• Patients scheduled for WBRT.
• Fully conscious patients who have been given written and verbal information, and have then provided informed consent.

You may not qualify if:

• Unstable medical condition, such as ischemic heart disease, liver disease or pulmonary disease, which may risk the patient during the study, as judged by the investigator.
• Renal failure, with serum creatinine \> 1.5mg/dl.
• Any known psychiatric disorder other than mild depression or anxiety.
• Patients treated for diabetes mellitus either by oral hypoglycemic medications or insulin.
• Allergy to any known medication or to any imaging agent, or allergy-originated diseases, as judged by the investigator.
• Other condition that might jeopardize the safety of the patient or the evaluation of the study results, as judged by the investigator.
• Treatment with any non-marketed investigational drug within 30 days prior to administration of \[18F\]-ML-10.
• Current alcohol or drug abuse
• Pregnancy or lactation.
• Women of child-bearing potential who are not using an adequate and medically acceptable contraceptive method.

Sponsors & Collaborators

• Aposense Ltd.: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

5-fluoropentyl-2-methylmalonic acid

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Aaron Allen, M.D.

  Rabin Medical Center, Petach Tikva 49100, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: November 14, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 13, 2013

Record last verified: 2013-02