RGD-K5 in Head and Neck Cancer Patients

NCT01447134 | Unknown DMC

• 1 other identifier: IRB99-3338A
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients.
2. 2.Secondary endpoint(s): To expand the safety database of \[F-18\]RGD-K5 and to correlate the parameters from the image study to clinical treatment response and prognosis.

Conditions

Head and Neck Neoplasms

Study Arms (3)

Surgical

Group (a) \[Those to undergo surgical excision or biopsy\] patients will receive RGD-K5 scan within two weeks of conventional image evaluations. The image result will be confirmed with histopathological results.

Chemotherapy concurrent Radiation

Group (b) patients \[Those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy\] will receive RGD-K5 scan prior to beginning of the therapy, after induction chemotherapy, within two weeks after concurrent chemoradiotherapy and two months after completion of concurrent chemoradiotherpy; all within two weeks of conventional image evaluations.

RGD-K5 scan

Group (c) patients \[Those with M1 disease to receive biotherapy or chemotherapy\] will receive RGD-K5 scan prior to the beginning of the first line systemic therapy, two weeks after beginning of the first line systemic therapy, within two weeks of first response evaluation for the first line systemic therapy, and within two weeks after end of the first line systemic therapy; each RGD-K5 scan would be performed within two weeks of conventional image studies. The systemic therapy might be biotherapy or chemotherapy.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 100 patients would be included. Group A would be those to undergo surgical excision or biopsy (n=20); Group B would be those with N2c-3M0 disease to receive chemotherapy followed by concurrent chemoradiotherapy (n=40); and Group C would be those with M1 disease to receive biotherapy or chemotherapy (n=40). Group A patients could be included into Group B or C if qualified.

You may qualify if:

• Head and neck cancer patients (including nasopharyngeal cancer)
• Age equals or more than 20 years old
• Referred by Chang Gung Memorial Hospital (CGMH) Head and Neck Oncology team.
• Willing to sign the informed consent

You may not qualify if:

• Patient who is pregnant or lactating;
• Patients with a concomitant or previous 2nd primary cancer other than head and neck malignancy;
• Unable to tolerate MR or PET/CT scan, such as those with magnetic implants (e.g. those received intracranial aneurysm surgery, cardiac pacemaker, artificial valves replacement, artificial ears), poor blood sugar control (fasting sugar more than 200 mg/dl), claustrophobia, unable to lie still.
• Unable to give informed consent

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Nuclear Medicine

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 6, 2011

Record last verified: 2011-10