Clinical trial · Interventional

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

An Open-Label Study to Evaluate 18F ML-10 as a PET Imaging Radiotracer for Early Detection of Response of Brain Metastases to Whole Brain Radiation Therapy (WBRT)

NCT00791063CI-TRIAL-00009454completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain Metastases	Brain Neoplasm	PROBABILISTIC	0.70
Solid Tumors	Solid Neoplasm	CURATED_BROADER	0.80

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
18F ML-10	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
18F ML-10
description
Intervention - 18F ML-10 PET/CT imaging for early detection of response of brain metastases to WBRT
interventionNames
1. Other: 18F ML-10

Primary outcomes (1)

measure
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.
timeFrame
3 months

Secondary outcomes (4)

measure
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.
timeFrame
3 months

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. 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.
2. Patients scheduled for WBRT.
3. Fully conscious patients who have been given written and verbal information, and have then provided informed consent.

Exclusion Criteria:

1. 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.
2. Renal failure, with serum creatinine \> 1.5mg/dl.
3. Any known psychiatric disorder other than mild depression or anxiety.
4. Patients treated for diabetes mellitus either by oral hypoglycemic medications or insulin.
5. Allergy to any known medication or to any imaging agent, or allergy-originated diseases, as judged by the investigator.
6. Other condition that might jeopardize the safety of the patient or the evaluation of the study results, as judged by the investigator.
7. Treatment with any non-marketed investigational drug within 30 days prior to administration of \[18F\]-ML-10.
8. Current alcohol or drug abuse
9. Pregnancy or lactation.
10. Women of child-bearing potential who are not using an adequate and medically acceptable contraceptive method.

References

Publications (0)

Data not yet available

No reference posted for this study.