99mTc-ADAPT6-based HER2 Imaging in Breast Cancer

NCT03991260 | Completed

• 2 other identifiers: 99mTc-ADAPT699mTc-ADAPT6 [TomskNRMC]
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer. The primary objective are:

1. 1.To assess distribution of 99mTc- ADAPT6 in normal tissues and in tumours over time;
2. 2.To assess kinetics of 99mTc- ADAPT6 in blood;
3. 3.To evaluate dosimetry of 99mTc- ADAPT6;
4. 4.To obtain initial information concerning safety and tolerability of 99mTc- ADAPT6 after single intravenous injection:

Conditions

Breast Cancer

Keywords

99mTc-ADAPT6; Breast Cancer; HER2 expression

Outcome Measures

Primary Outcomes (4)

• Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%)

  Whole-body 99mTc-ADAPT6 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical

  6 hours

• SPECT-based 99mTc-ADAPT6 uptake value in tumor lesions (kcounts)

  99mTc-ADAPT6 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in kcounts

  6 hours

• SPECT-based 99mTc-ADAPT6 background uptake value (kcounts)

  Focal uptake of 99mTc-ADAPT6 in the regions without pathological findings will be assessed with SPECT and measured in kcounts

  6 hours

• Tumor-to-background ratio (SPECT)

  The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ADAPT6 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ADAPT6 uptake coinciding with the regions without pathological findings (kcounts)

  6 hours

Secondary Outcomes (4)

• Safety attributable to 99mTc-ADAPT6 injections (physical findings)

  24 hours

• Safety attributable to 99mTc-ADAPT6 injections (laboratory tests)

  24 hours

• Safety attributable to 99mTc-ADAPT6 injections (incidence and severity of adverse events)

  24 hours

• Safety attributable to 99mTc-ADAPT6 injections (concomitant medication)

  24 hours

Study Arms (2)

The tested injected doses of 99mTc- ADAPT6 500 µg

At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 500 µg. Subjects withdrawn from the study for any reason will be replaced.

Diagnostic Test: SPECT

The tested injected doses of 99mTc- ADAPT6 1000 µg

At least five (5) evaluable subjects with HER2-positive status and at least three (3) subjects with HER2-negative status have to be enrolled in the study for each tested protein dose. The tested injected dose is 1000 µg. Subjects withdrawn from the study for any reason will be replaced.

Diagnostic Test: SPECT

Interventions

SPECT DIAGNOSTIC_TEST

One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.

The tested injected doses of 99mTc- ADAPT6 1000 µg; The tested injected doses of 99mTc- ADAPT6 500 µg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary HER2-positive and HER2-negative breast cancer.

You may qualify if:

• Subject is \> 18 years of age
• Diagnosis of primary breast cancer with possible lymph node metastases
• Availability of results from HER2 status previously determined on material from the primary tumor, either
• HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
• HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
• Volumetrically quantifiable tumour lesions on CT or MRI, with at least one lesion \> 1.0 cm in greatest diameter outside of the liver and kidneys
• Hematological, liver and renal function test results within the following limits:
• White blood cell count: \> 2.0 x 10\^9/L
• Haemoglobin: \> 80 g/L
• Platelets: \> 50.0 x 10\^9/L
• ALT, ALP, AST: =\< 5.0 times Upper Limit of Normal
• Bilirubin =\< 2.0 times Upper Limit of Normal
• Serum creatinine: Within Normal Limits
• A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination
• Subject is capable to undergo the diagnostic investigations to be performed in the study

You may not qualify if:

• Second, non-breast malignancy
• Active current autoimmune disease or history of autoimmune disease
• Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening)
• Known HIV positive or chronically active hepatitis B or C
• Administration of other investigational medicinal product within 30 days of screening
• Ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead
• KTH Royal Institute of Technology: collaborator
• Uppsala University: collaborator

Study Sites (1)

TomskNRMC

Tomsk, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Vladimir I Chernov, MD, Prof.

  TomskNMRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 19, 2019
• Study Start: June 5, 2019
• Primary Completion: June 5, 2020
• Study Completion: September 5, 2020
• Last Updated: April 1, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)