An Efficacy and Safety Study to Assess [18F]-ML-10 in Detecting Response of Tumors to Chemotherapy and Radiation

NCT01260480 | Unknown Phase 2

• 1 other identifier: NST-CA007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine whether \[18F\]-ML-10 used in conjunction with PET imaging is effective as an imaging tool for the early detection of response of oncological tumors in the lungs,head and neck to chemoradiation therapy. The study will evaluate the potential of \[18F\]-ML-10 used in conjunction with PET imaging to distinguish early during the course of chemoradiation therapy between a tumor that responds to the therapy, and a tumor that does not respond to the therapy. Currently, this distinction is available to the physician several weeks or months after completion of therapy, using anatomical imaging (for example Computed Tomography \[CT\] or Magnetic Resonance Imaging \[MRI\]).

Conditions

Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms

Keywords

Carcinoma, non-small-cell lung; Head and neck neoplasms; Diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• To characterize changes in [18F]-ML-10 uptake in the target lesion in response to chemoradiotherapy.

  Between baseline and day 11 ± 1, and between baseline and day 18 ± 1

Secondary Outcomes (4)

• To assess the correlation between the changes in the uptake of [18F]-ML-10 in the target lesion and the changes in the anatomical dimensions of the target lesion.

• To identify at least one parameter, derived from the changes in [18F]-ML-10 uptake that can discriminate tumors responsive to treatment from tumors that are non-responsive.

• To perform additional analyses for all other lesions and lymph nodes with at least one diameter ≥ 2 cm treated by concurrent CRT.

• To assess the safety of [18F]-ML-10 administered to cancer patients receiving concurrent CRT.

Study Arms (1)

[18F]-ML-10

EXPERIMENTAL

Other: [18F]-ML-10 in conjunction with PET imaging

Interventions

[18F]-ML-10 in conjunction with PET imaging OTHER

Subjects will receive two to three intravenous (IV) doses of \[18F\]-ML-10. The dose for each \[18F\]-ML-10 dose will be 5.50 MBq/Kg or 0.15 mCi/Kg but will not exceed 500.00 MBq (13.50 mCi) per administration.

[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:

• Male or female patients with either:
• Newly diagnosed non small cell lung cancer (NSCLC) (Group A) who meet the following criteria:
• Previously untreated, histologically or cytologically confirmed stage IIB, IIIA or IIIB disease, without evidence of distant metastases
• A measurable primary tumor with at least one diameter \> 2 cm or primary tumor extending to one or more lymph nodes which cannot be distinctively delineated as confirmed by a diagnostic quality chest CT performed within 4 weeks prior to initiation of the concurrent CRT.
• Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
• Undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
• GBCA-enhanced Brain MRI or contrast enhanced CT if there are signs or symptoms suggesting brain metastases within the past 2 months.
• If necessary to confirm stage of disease, an upper abdomen CT scan will be performed.
• whole-body FDG PET/CT; OR
• Newly diagnosed squamous cell carcinoma of the head and neck (SCCHN) (Group B) who meet the following criteria:
• Previously untreated, histologically or cytologically confirmed (from the primary tumor and/or lymph nodes) stage III-IV disease without evidence of distant metastases.
• A measurable (i) primary tumor with at least one diameter ≥2 cm and (ii) lymph node with at least one diameter ≥ 2 cm as confirmed by a diagnostic quality neck CT performed within 4 weeks prior to initiation of the concurrent CRT.
• Planned to receive concurrent chemoradiotherapy as definitive treatment. The radiation dose should not exceed 70 Gy.
• Have undergone the following minimum workup to confirm disease staging within 4 weeks prior to initiation of the concurrent CRT:
• Whole-body FDG PET/CT.

You may not qualify if:

• Predominant small cell carcinoma histology.
• Pure bronchioalveolar cell carcinoma histology.
• Treatment planned with chemotherapy other than a platinum-based doublet regimen.
• Malignant pleural or pericardial effusions.
• Any contraindication to perform CT with IV contrast agent.
• Histology other than squamous cell carcinoma.
• Treatment planned with chemotherapy other than a platinum-based regimen.
• Treatment planned with cetuximab.
• Treatment with induction chemotherapy.
• Any contraindication to CT with IV contrast agent.
• Evidence of distant metastases.
• Patients who, based on the investigator's judgment, have other unstable medical conditions that may preclude safe and complete study participation.
• Treatment with any investigational drug, device or biologic agent within 30 days prior to administration of \[18F\]-ML-10.
• Pregnancy or lactation.

Sponsors & Collaborators

• Aposense Ltd.: lead

Study Sites (4)

BWH

Boston, Massachusetts, United States

RECRUITING

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

RECRUITING

Mount Sinai

New York, New York, 10029, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms

Interventions

5-fluoropentyl-2-methylmalonic acid; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Heron Dwight, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• David Sher, MD, MPH

  BWH, Harvard

  PRINCIPAL INVESTIGATOR

• Aaron Allen, MD

  Rabin Medical Center

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 15, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2012
• Last Updated: December 17, 2010

Record last verified: 2010-12

Locations

US (4)