A Study of [F-18]HX4 (PET Imaging)Evaluated in Head and Neck Cancer Patients

NCT01506427 | Withdrawn Phase 1

• 1 other identifier: HX4-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to determine what will be the optimal imaging protocol for Head and Neck Cancer patients after \[F-18\] HX4 injection. This study will provide guidance for future studies involving \[F-18\]HX4 in cancer patients.

Conditions

Head and Neck Cancer

Keywords

Newly Diagnosed; Head and Neck Cancer; PET Imaging

Outcome Measures

Primary Outcomes (1)

• Serial measures of T/B Ratios and other imaging parameters

  Serial measures of T/B ratios and other imaging parameters derived from the course imaging data of head and neck cancer pateitns in order to determine time of optimal imaging.

  Approximately 1 month after patient imaging; comprehensive analysis will be concluded within 1 month after Last Patient Out

Secondary Outcomes (3)

• Correlations between T/B ratios of [F-18]HX4 uptake from pre-surgery PET imaging and immunohistochemistry measurements

  Estimated analysis to occur 1 month after patient surgery

• Kinetic Modeling Analysis

  Estimated to be 2 weeks after the Imaging Date (Visit 2)

• Safety Assessments

  On average of 3 weeks (from Time of Signing Consent to 24 hours after the Imaging Date)

Study Arms (1)

[F-18] HX4

EXPERIMENTAL

Radiation: [F-18] HX4

Interventions

[F-18] HX4 RADIATION

A single dose of 10 mCi, injected intravenously.

[F-18] HX4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is \>18 years and male or female of any race / ethnicity.
• Patient or patient's legally acceptable representative provides written inform consent Patient is willing and able to comply with protocol procedures.
• Patient has newly diagnosed histologically confirmed squamous cell carcinoma of the head and/or neck whose primary origin is from the oral cavity, oropharynx, hypopharynx, larynx or nasopharynx.
• Patient is scheduled to have or already has had a clinical \[F-18\]FDG PET/CT scan prior (recommended to be within 14 days prior) to the \[F-18\]HX4 PET/CT scan.
• Patient has a primary tumor ≥ 2.0 cm in longest axis measured by CT or MR; or lymph node ≥ 2.0 cm in shortest axis measured by CT or MR if primary tumor \< 2 cm on CT or MR; CT may be part of required \[F-18\]FDG PET/CT scan or a separate pre-surgery CT scan.
• Patient is scheduled to undergo complete tumor resection within 7 days for his/her cancer care after the \[F-18\]HX4 PET/CT scan is performed.
• Patient has not had nor will have neoadjuvant treatment, including radiation and chemotherapy, prior to patient's planned tumor resection.

You may not qualify if:

• Female patient is pregnant or nursing.
• Patient is not capable of remaining still for duration of imaging procedure (\~ 4 hours).
• Patient has undergone an investigative, radioactive research procedure within 7 days prior to study participation, or is scheduled to undergo such a procedure during the study participation period.
• Patient has chronic renal function failure or is on renal dialysis
• Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete data.

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (1)

University of Iowa Medical Center

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• John Buatti, MD

  University of Iowa Medical Center

  PRINCIPAL INVESTIGATOR

• Edward Aten, MD

  President, Certus International

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: January 10, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

US (1)