Clinical trial · Observational

RGD-K5 in Head and Neck Cancer Patients

Phase II Study of [18F]RGD-K5 in Head and Neck Cancer Patients

NCT01447134CI-TRIAL-00005596unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

1. Primary endpoint(s): To determine the relationship between the drug distribution and angiogenesis in head and neck cancer patients. 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

Conditions (1)

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

Condition (as posted)	Mapped entity	Match	Confidence
Head and Neck Neoplasms	Head and Neck Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (3)

label
Surgical
description
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.
label
Chemotherapy concurrent Radiation
description
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.
label
RGD-K5 scan
description
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.

Primary outcomes (0)

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Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 20 Years

Show eligibility criteria text

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

References

Publications (0)

Data not yet available

No reference posted for this study.