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99mTc-ADAPT6-based HER2 Imaging in Breast Cancer (99mTc-ADAPT6)

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ClinicalTrials.gov Identifier: NCT03991260
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
KTH Royal Institute of Technology
Uppsala University
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

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

The secondary objective is:

1.To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:


Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: SPECT

Detailed Description:

Overall goal of the project: To determine HER2 expression level in primary breast cancer and possibly in axillary lymph node metastases before neoadjuvant trastuzumab therapy.

Phase I. Distribution of 99mTc-ADAPT6 in patients with primary breast cancer. The study should evaluate distribution of 99mTc- ADAPT6 in patients with primary HER2-positive and HER2-negative breast cancer.

The primary objective are:

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

The secondary objective is:

1. To compare the tumour imaging data with the concerning HER2 expression obtained by immunohistochemistry (IHC) or fluorescent in situ hybridisation (FISH) analysis of biopsy samples:

Methodology:

Open-label, exploratory, single centre study. The subjects will receive a single injection of the labelled tracer.


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Study Type : Observational
Estimated Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SPECT Imaging of HER2 Expression in Breast Cancer Using Technetium-99m-labelled ADAPT6
Actual Study Start Date : June 5, 2019
Estimated Primary Completion Date : June 5, 2020
Estimated Study Completion Date : June 5, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Gamma camera-based whole-body 99mTc-ADAPT6 uptake value (%) [ Time Frame: 6 hours ]
    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

  2. SPECT-based 99mTc-ADAPT6 uptake value in tumor lesions (kcounts) [ Time Frame: 6 hours ]
    99mTc-ADAPT6 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in kcounts

  3. SPECT-based 99mTc-ADAPT6 background uptake value (kcounts) [ Time Frame: 6 hours ]
    Focal uptake of 99mTc-ADAPT6 in the regions without pathological findings will be assessed with SPECT and measured in kcounts

  4. Tumor-to-background ratio (SPECT) [ Time Frame: 6 hours ]
    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)


Secondary Outcome Measures :
  1. Safety attributable to 99mTc-ADAPT6 injections (physical findings) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the assessments of physical examination, vital signs, and ECG (% of cases with abnormal findings relative to baseline)

  2. Safety attributable to 99mTc-ADAPT6 injections (laboratory tests) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the blood and urine laboratory tests (% of cases with abnormal findings relative to baseline)

  3. Safety attributable to 99mTc-ADAPT6 injections (incidence and severity of adverse events) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of adverse events (%)

  4. Safety attributable to 99mTc-ADAPT6 injections (concomitant medication) [ Time Frame: 24 hours ]
    The safety attributable to 99mTc-ADAPT6 injections will be evaluated based on the rate of administration of concomitant medication (%)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with primary HER2-positive and HER2-negative breast cancer.
Criteria

Inclusion Criteria:

  1. Subject is > 18 years of age
  2. Diagnosis of primary breast cancer with possible lymph node metastases
  3. Availability of results from HER2 status previously determined on material from the primary tumor, either

    1. HER2-positive, defined as a DAKO HercepTest™ score of 3+ or FISH positive or
    2. HER2-negative, defined as a DAKO HercepTest™ score of 0 or 1+; or else if 2+ then FISH negative
  4. 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
  5. 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
  6. 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
  7. Subject is capable to undergo the diagnostic investigations to be performed in the study

11. Informed consent

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991260


Locations
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Russian Federation
TomskNRMC
Tomsk, Russian Federation
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
KTH Royal Institute of Technology
Uppsala University
Investigators
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Principal Investigator: Vladimir I Chernov, MD, Prof. TomskNMRC

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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT03991260     History of Changes
Other Study ID Numbers: 99mTc-ADAPT6
99mTc-ADAPT6 [TomskNRMC] ( Other Identifier: TomskNRMC )
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
99mTc-ADAPT6
Breast Cancer
HER2 expression

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases