Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans

NCT02970786 | Unknown Phase 1

• 1 other identifier: AK-2015-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E\[c(RGDyK)\]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment. This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

Conditions

Neuroendocrine Carcinoma; Breast Cancer; Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• Biodistribution

  Change in biodistribution estimated by PET

  2 hours

• Dosimetry

  Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c\[RGDyK\])2.

  2 hours

• Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data.

  48 hours

Secondary Outcomes (1)

• Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue

  2 hours

Study Arms (1)

68Ga-NODAGA-E(c[RGDyK])2 PET

EXPERIMENTAL

One injection of 68Ga-NODAGA-E(c\[RGDyK\])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection

Drug: Injection of 68Ga-NODAGA-E(c[RGDyK])2

Interventions

Injection of 68Ga-NODAGA-E(c[RGDyK])2 DRUG

Following one injection of 68Ga-NODAGA-E(c\[RGDyK\])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection

68Ga-NODAGA-E(c[RGDyK])2 PET

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
• Capable of understanding and giving full informed consent

You may not qualify if:

• Pregnancy
• Lactation
• Obesity (weight above 140 kg)
• Claustrophobia

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Malene M Clausen, MD, PhD

CONTACT

+4522524536; malene.martini.clausen@regionh.dk

Andreas Kjaer, Professor

CONTACT

+4535454011; andreas.kjaer@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 22, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2017
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)