Ga-68-DOTA-RGD2 PET/CT in patients with head and neck cancer: a potential tracer to image angiogenesis in tumors.

Ga-68-DOTA-RGD2 PET/CT in patients with head and neck cancer: a potential tracer to image angiogenesis in tumors. - PET/CT imaging with Ga-68-DOTA-RGD2 in HNSCC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43594

Enrollment

Registered

2015-07-03

Start date

2016-02-03

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer HNSCC

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Proven HNSSC of the oral cavity, oro- and hypopharynx, or larynx - At least one lesion with a diameter of at least 1.5 cm - A diagnostic CT or MRI scan is obtained within 4 weeks prior to screenings visit - Planned surgery as primary treatment - * 18 years - Ability to provide written informed consent

Exclusion criteria

Exclusion criteria: - Contra-indications for PET: pregnancy, breast-feeding, or severe claustrophobia - Abnormal renal function * creatinine clearance * 60 mL/min according to the formula of Cockroft and Gault - Abnormal liver function * ALAT or ASAT level more than 3 times the upper limit of normal range * Bilirubin more than 2 times the upper limit of normal range - Other serious illness

Design outcomes

Primary

Measure	Time frame
The main study parameter is the uptake of Ga-68-DOTA-RGD2 in the tumor lesions as quantified by PET/CT. Therefore, tracer uptake in tumor tissue, liver, muscle and blood will be determined quantitatively (Standardized Uptake Values, SUVs). With the SUVs, tumor-to-blood and tumor-to-background ratios are calculated. SUVs are obtained by drawing regions of interest, drawn by an investigator, blinded for the immunohistochemical data. Positive ratios are defined as a ratio higher or equal to 2.	—

Measure

Time frame

The main study parameter is the uptake of Ga-68-DOTA-RGD2 in the tumor lesions as quantified by PET/CT. Therefore, tracer uptake in tumor tissue, liver, muscle and blood will be determined quantitatively (Standardized Uptake Values, SUVs). With the SUVs, tumor-to-blood and tumor-to-background ratios are calculated. SUVs are obtained by drawing regions of interest, drawn by an investigator, blinded for the immunohistochemical data. Positive ratios are defined as a ratio higher or equal to 2.

—

Secondary

Measure	Time frame
Additional study parameters are the pharmacokinetics, pharmacodynamics, biodistribution and in vivo stability of Ga-68-DOTA-RGD2, and integrin v3 expression of the tumor lesion as determined immunohistochemically.	—

Countries

Netherlands

Outcome results