Molecular Imaging of HER2 Expression in Breast Cancer Using 99mTc-ZHER2.

NCT05203497 | Completed Phase 1

• 1 other identifier: 99mTc-ZHER2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study should evaluate distribution of 99mTc-ZHER2:41071 Affibody molecule in patients with primary HER2-positive and HER2-negative breast cancer The primary objectives are:

1. 1.To assess distribution of 99mTc-ZHER2:41071 in normal tissues and in tumors over time;
2. 2.To evaluate dosimetry of 99mTc-ZHER2:41071;
3. 3.To obtain initial information concerning safety and tolerability of 99mTc-ZHER2:41071 after single intravenous injection:

Conditions

Breast Cancer Female

Keywords

99mTc-ZHER2:41071; Breast Cancer; HER2 expression

Outcome Measures

Primary Outcomes (4)

• Gamma camera-based whole-body 99mTc-ZHER2:41071 uptake value (% per organ)

  Whole-body 99mTc-ZHER2:41071 uptake coinciding with normal organs and tissues will be assessed using gamma camera at 2, 4, 6 and 24 hours after injection and calculated as percentage (%) of the injected dose of the radiopharmaceutical

  24 hours

• SPECT/CT-based 99mTc-ZHER2:41071 uptake value in tumor lesions (kcounts)/SUV

  99mTc-ZHER2:41071 focal uptake coinciding with tumor lesions will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV

  6 hours

• SPECT-based 99mTc-ZHER2:41071 background uptake value (kcounts)/SUV

  Uptake of 99mTc-ZHER2:41071 in the regions without pathological findings will be assessed using SPECT/CT at 2, 4 and 6 hours after injection and measured in kcounts and SUV.

  6 hours

• Tumor-to-background ratio (SPECT)

  The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-ZHER2:41071 uptake coinciding with tumor lesions (kcounts) will be divided by the value of 99mTc-ZHER2:41071 uptake coinciding with the regions without pathological findings (kcounts)

  6 hours

Secondary Outcomes (7)

• Safety attributable to 99mTc-ZHER2:41071 injections (physical examination)

  24 hours

• Safety attributable to 99mTc-ZHER2:41071 injections (vital signs)

  24 hours

• Safety attributable to 99mTc-ZHER2:41071 injections (ECG )

  24 hours

• Safety attributable to 99mTc-ZHER2:41071 injections (blood laboratory tests)

  24 hours

• Safety attributable to 99mTc-ZHER2:41071 injections (urine laboratory tests)

  24 hours

Study Arms (2)

The tested injected doses of 99mTc-ZHER2:41071 500 μg

EXPERIMENTAL

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

Drug: SPECT

The tested injected doses of 99mTc-ZHER2:41071 1000 μg

EXPERIMENTAL

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

Drug: SPECT

Interventions

SPECT DRUG

One single injection of 99mTc-ZHER2:41071, followed by gamma camera imaging after 2, 4, 6 and 24 hours.

Also known as: 99mTc-ZHER2:41071

The tested injected doses of 99mTc-ZHER2:41071 1000 μg; The tested injected doses of 99mTc-ZHER2:41071 500 μg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women with primary breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 \> 2.0 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 109/L
• Hemoglobin: \> 80 g/L
• Platelets: \> 50.0 x 109/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 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

Study Sites (1)

TomskNRMC

Tomsk, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Vladimir Chernov, MD, Prof.

  Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 24, 2022
• Study Start: December 22, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

RU (1)